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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K965228
Device Name FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact MELISSA MAZZONI
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact MELISSA MAZZONI
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/31/1996
Decision Date 11/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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