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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dermatome
510(k) Number K940208
Device Name AESCULAP ACCU-DERMATOME
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 Number878.4820
Classification Product Code
GFD  
Date Received01/14/1994
Decision Date 02/24/1994
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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