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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K964215
Device Name ACUFEX MOSAICPLASTY COMPREHENSIVE 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 Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HWE  
Date Received10/22/1996
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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