The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acry Island Border Dressing, Models 2031, 2032, 2033.
| Device ID | K992032 |
| 510k Number | K992032 |
| Device Name: | ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 |
| Classification | Bandage, Liquid |
| 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 | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-16 |
| Decision Date | 1999-08-19 |
| Summary: | summary |