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Data / Medical devices / United States / Pepper Medical, Inc.

Pepper Medical, Inc.: FDA-registered device maker in West Chester, PA, United States, 2 510(k) clearances

Pepper Medical, Inc. is registered with the FDA (registration 2529776) in West Chester, PA, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 13, 2004. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
2529776
FEI number
1000121196
Address
600 W Strasburg Rd, West Chester, PA, United States, 19382
Owner or operator
PEPPER MEDICAL, INC. (9006041)
Roles
Repackager or relabeler, Specification developer
First device listed
November 2, 2001
Registered through
2027
Brand names listed
AVALON AIRE HEADSTRAP, Bacterial Viral Filter, Closed Suction Catheter, ENDO-TIE, Endo-Tie, PreVent Endo Holder, Foley Loc, Foley Tube Holder, Foley-Patch and more

Devices it lists

DeviceProduct codeClassRoleSource
Bag, ReservoirBTC1Repackager or relabeleraccessdata.fda.gov
Binder, AbdominalFSD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Repackager or relabeler, Specification developeraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Repackager or relabeler, Specification developeraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeleraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Repackager or relabeler, Specification developeraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Support, Breathing TubeJAY1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeler, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 13, 2004K033008AIR SAFETY HEPA AND NON-HEPA FILTERSCAHSubstantially EquivalentAir Safety, Ltd.accessdata.fda.gov
June 14, 1985K851070RESP-BAC BACTERIA FILTERCAHSubstantially EquivalentMedicomp, Inc.accessdata.fda.gov

Compare with other makers

Updated May 13, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.