FDA 510(k) Application Details - K971680

Device Classification Name Wax,Bone

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510(K) Number K971680
Device Name Wax,Bone
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact MELISSA MAZZONI
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Regulation Number 000.0000

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Classification Product Code MTJ
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Date Received 05/07/1997
Decision Date 10/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K971680


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