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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name guide, needle, surgical
510(k) Number K950007
Device Name SURGICAL INSTRUMENT GUIDE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact JANET G JOHNSON
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact JANET G JOHNSON
Regulation Number878.4800
Classification Product Code
GDF  
Date Received01/03/1995
Decision Date 03/15/1995
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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