The following data is part of a premarket notification filed by Strukmyer Medical with the FDA for Comatryx Collagen Wound Dressing 1 Gram Pouch, Comatryx Collagen Wound Dressing 1 Gram Vial, Comatryx Collagen Wound Dressing 10 Gram Bottle.
| Device ID | K171645 |
| 510k Number | K171645 |
| Device Name: | CoMatryx Collagen Wound Dressing 1 Gram Pouch, CoMatryx Collagen Wound Dressing 1 Gram Vial, CoMatryx Collagen Wound Dressing 10 Gram Bottle |
| Classification | Dressing, Wound, Collagen |
| Applicant | Strukmyer Medical 1801 Big Town Blvd Suite #100 Mesquite, TX 75149 |
| Contact | Pamela Liberto |
| Correspondent | Pamela Liberto Strukmyer Medical 1801 Big Town Blvd Suite #100 Mesquite, TX 75149 |
| 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 | 2017-06-05 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00714196933317 | K171645 | 000 |
| 50850003042225 | K171645 | 000 |
| 50850003042201 | K171645 | 000 |
| 00850003042329 | K171645 | 000 |