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Data / Medical devices / United States / M. C. Johnson Co., Inc.

M. C. Johnson Co., Inc.: FDA-registered device maker in Ft Myers, FL, United States, 1 510(k) clearance

M. C. Johnson Co., Inc. is registered with the FDA (registration 1219821) in Ft Myers, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1219821
Address
Suite Business Park Drive, Ft Myers, FL, United States, 33912
Owner or operator
M.C. JOHNSON CO., INC. (1219821)
Roles
Complaint file establishment, Specification developer
First device listed
November 23, 2011
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Bedding, Disposable, MedicalKME1Specification developeraccessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-SterileNNX1Complaint file establishment, Specification developeraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Specification developeraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Complaint file establishmentaccessdata.fda.gov
Polymer Patient Examination GloveLZA1Complaint file establishmentaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification 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
November 15, 2017K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsLZASubstantially EquivalentZhonghong Pulin Medical Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated November 15, 2017. 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.