510(k) K936186

AESCULAP SKIN GRAFT MESHER by Aesculap, Inc. — Product Code FZW

K936186 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP SKIN GRAFT MESHER". The FDA issued a decision of Substantially Equivalent on March 10, 1994. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1994
Date Received
December 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Surgical, Skin Graft
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type