FDA 510(k) Application Details - K982754

Device Classification Name Camera, Television, Endoscopic, Without Audio

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510(K) Number K982754
Device Name Camera, Television, Endoscopic, Without Audio
Applicant A. STEIN - REGULATORY AFFAIRS CONSULTING
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact AHAVA STEIN
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Regulation Number 878.4160

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Classification Product Code FWF
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Date Received 08/06/1998
Decision Date 01/08/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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