The following data is part of a premarket notification filed by Mariner Biomedical, Inc. with the FDA for Advanced Care Hydrophilic Wound Dressings.
| Device ID | K961662 |
| 510k Number | K961662 |
| Device Name: | ADVANCED CARE HYDROPHILIC WOUND DRESSINGS |
| Classification | Bandage, Liquid |
| Applicant | MARINER BIOMEDICAL, INC. 73 FAULKNER DR. Guilford, CT 06437 |
| Contact | Richard E Galardy |
| Correspondent | Richard E Galardy MARINER BIOMEDICAL, INC. 73 FAULKNER DR. Guilford, CT 06437 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-30 |
| Decision Date | 1996-06-13 |
| Summary: | summary |