The following data is part of a premarket notification filed by Organogenesis Inc. with the FDA for Puraply Micronized Wound Matrix (puraply Mz).
| Device ID | K220317 |
| 510k Number | K220317 |
| Device Name: | PuraPly Micronized Wound Matrix (PuraPly MZ) |
| Classification | Dressing, Wound, Collagen |
| Applicant | Organogenesis Inc. 150 Dan Road Canton, MA 02021 |
| Contact | Kurdea Lyon |
| Correspondent | Kurdea Lyon Organogenesis Inc. 150 Dan Road Canton, MA 02021 |
| 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 | 2022-02-03 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00618474000411 | K220317 | 000 |
| 00618474000404 | K220317 | 000 |
| 00618474000398 | K220317 | 000 |