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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic manual surgical instrument
510(k) Number K001507
Device Name MICROPERFORATION INSTRUMENT
Original Applicant
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield,  MA  02048
Original Contact nicholas condakes
Regulation Number888.4540
Classification Product Code
LXH  
Date Received05/15/2000
Decision Date 06/14/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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