Data / Medical devices / United States / Harbor Medtech, Inc.
Harbor Medtech, Inc.: FDA-registered device maker in Lake Forest, CA, United States, 2 510(k) clearances
Harbor Medtech, Inc. is registered with the FDA (registration 3010097129) in Lake Forest, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010097129
- Address
- 21076 Bake Parkway Suite 100, Lake Forest, CA, United States, 92630
- Owner or operator
- Harbor MedTech, Inc. (10090866)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 24, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2014 | K140367 | ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX | KGN | Substantially Equivalent | Harbor Medtech, Inc. | accessdata.fda.gov |
| February 26, 2013 | K122502 | BRIDGE EXTRACELLULAR COLLEGEN MATRIX | KGN | Substantially Equivalent | Harbor Medtech, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2014. 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.