The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Modification To Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045.
| Device ID | K002599 |
| 510k Number | K002599 |
| Device Name: | MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 |
| Classification | Dressing, Wound, Drug |
| Applicant | ACRYMED, INC. 12232 S.W. GARDEN PL. Portland, OR 97223 |
| Contact | Bruce Gibbons |
| Correspondent | Bruce Gibbons 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-09-21 |