The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Gel Wound Dressing.
| Device ID | K970693 |
| 510k Number | K970693 |
| Device Name: | ACRYDERM GEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | ACRYMED, INC. 12232 S.W. GARDEN PL. Portland, OR 97223 |
| Contact | Bruce Gibbins |
| Correspondent | Bruce Gibbins ACRYMED, INC. 12232 S.W. GARDEN PL. Portland, OR 97223 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-03-21 |
| Summary: | summary |