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 |