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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, surgical instrument, ac-powered
510(k) Number K962789
Device Name SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
Applicant
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact TEDD GOSIAN
Correspondent
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact TEDD GOSIAN
Regulation Number878.4820
Classification Product Code
GEY  
Date Received07/17/1996
Decision Date 08/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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