The following data is part of a premarket notification filed by Marine Polymer Technologies, Inc. with the FDA for Mrdh Bandage.
| Device ID | K082703 |
| 510k Number | K082703 |
| Device Name: | MRDH BANDAGE |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2008-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10389142000121 | K082703 | 000 |
| 10389142000114 | K082703 | 000 |