FDA 510(k) Application Details - K982397

Device Classification Name Camera, Television, Endoscopic, Without Audio

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510(K) Number K982397
Device Name Camera, Television, Endoscopic, Without Audio
Applicant ANGIOLAZ, INC.
INDUSTRIAL PARK
BELLOWS FALLS, VT 05101-0556 US
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Contact JOHN D PLUMADORE
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Regulation Number 878.4160

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Classification Product Code FWF
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Date Received 07/09/1998
Decision Date 09/10/1998
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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