The following data is part of a premarket notification filed by Harbor Medtech, Inc. with the FDA for Architect Px Extracellular Collagen Matrix.
| Device ID | K140367 |
| 510k Number | K140367 |
| Device Name: | ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | HARBOR MEDTECH, INC. 4 JENNER SUITE 190 Irvine, CA 92618 |
| Contact | Jerry Mezger |
| Correspondent | Jerry Mezger HARBOR MEDTECH, INC. 4 JENNER SUITE 190 Irvine, CA 92618 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-12 |
| Summary: | summary |