The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Silver Antimicrobial Strands Model A-020103.
| Device ID | K002909 |
| 510k Number | K002909 |
| Device Name: | ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2000-10-13 |