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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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