FDA 510(k) Application Details - K923160

Device Classification Name Camera, Television, Endoscopic, Without Audio

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510(K) Number K923160
Device Name Camera, Television, Endoscopic, Without Audio
Applicant AMERICAN SURGICAL TECHNOLOGIES CORP.
88 ESSEX ST.
HAVERHIILL, MA US
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Contact P.FALLON III
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Regulation Number 878.4160

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Classification Product Code FWF
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Date Received 06/29/1992
Decision Date 12/10/1992
Decision SE - Substantially Equivalent
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



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