The following data is part of a premarket notification filed by Rynel Ltd, Inc. with the FDA for Epitech Island Dressings.
| Device ID | K971337 |
| 510k Number | K971337 |
| Device Name: | EPITECH ISLAND DRESSINGS |
| Classification | Bandage, Liquid |
| Applicant | RYNEL LTD, INC. ROUTE 27 Boothbay, ME 04537 |
| Contact | Tim Thomson |
| Correspondent | Tim Thomson RYNEL LTD, INC. ROUTE 27 Boothbay, ME 04537 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-07-09 |
| Summary: | summary |