FDA 510(k) Application Details - K972810

Device Classification Name Table, Operating-Room, Ac-Powered

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510(K) Number K972810
Device Name Table, Operating-Room, Ac-Powered
Applicant O.P.T. USA, INC.
235 SACKETT ST.
BROOKLYN, NY 11231 US
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Contact MARIA CORIA
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Regulation Number 878.4960

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Classification Product Code FQO
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Date Received 07/28/1997
Decision Date 08/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
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 K972810


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