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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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More FDA Info for this Product Code
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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