The following data is part of a premarket notification filed by Dermatological Research Laboratories, Inc. with the FDA for Post Surgical Kit/post Biopsy Kit.
| Device ID | K910011 |
| 510k Number | K910011 |
| Device Name: | POST SURGICAL KIT/POST BIOPSY KIT |
| Classification | Wound Dressing Kit |
| Applicant | DERMATOLOGICAL RESEARCH LABORATORIES, INC. 577 AIRPORT BLVD., SUITE 130 Burlingame, CA 94010 |
| Contact | Kevin Day |
| Correspondent | Kevin Day DERMATOLOGICAL RESEARCH LABORATORIES, INC. 577 AIRPORT BLVD., SUITE 130 Burlingame, CA 94010 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-02 |
| Decision Date | 1991-03-27 |