The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Absorbent Oxygen Dressing.
| Device ID | K082459 |
| 510k Number | K082459 |
| Device Name: | ACRYDERM ABSORBENT OXYGEN DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ACRYMED, INC. 9560 SW NIMBUS AVE Beaverton, OR 97008 |
| Contact | Bruce Gibbins |
| Correspondent | Bruce Gibbins ACRYMED, INC. 9560 SW NIMBUS AVE Beaverton, OR 97008 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-08-26 |
| Decision Date | 2008-09-19 |
| Summary: | summary |