The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Silver Antimicrobial Foam Wound Dressing.
| Device ID | K091354 |
| 510k Number | K091354 |
| Device Name: | ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ACRYMED, INC. 9560 SW NIMBUS AVE Beaverton, OR 97008 |
| Contact | Charles K Griffin |
| Correspondent | Charles K Griffin 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 | 2009-05-08 |
| Decision Date | 2009-10-21 |
| Summary: | summary |