The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Skin Graft Mesher.
Device ID | K936186 |
510k Number | K936186 |
Device Name: | AESCULAP SKIN GRAFT MESHER |
Classification | Expander, Surgical, Skin Graft |
Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
Contact | Mary Ellen Holden |
Correspondent | Mary Ellen Holden AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
Product Code | FZW |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-23 |
Decision Date | 1994-03-10 |