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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name expander, surgical, skin graft
510(k) Number K936186
Device Name AESCULAP SKIN GRAFT MESHER
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact MARY ELLEN HOLDEN
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact MARY ELLEN HOLDEN
Regulation Number878.4800
Classification Product Code
FZW  
Date Received12/23/1993
Decision Date 03/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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