The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Modification To Skvekpatch.
Device ID | K984177 |
510k Number | K984177 |
Device Name: | MODIFICATION TO SKVEKPATCH |
Classification | Bandage, Liquid |
Applicant | MARINE POLYMER TECHNOLOGIES, INC. 107 WATER ST. Danvers, MA 01923 |
Contact | Sergio Finkielsztein |
Correspondent | Sergio Finkielsztein MARINE POLYMER TECHNOLOGIES, INC. 107 WATER ST. Danvers, MA 01923 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-20 |
Decision Date | 1998-12-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10389142000084 | K984177 | 000 |