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 |