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FDA 510(k) Application Details - K990731
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K990731
Device Name
Laparoscope, General & Plastic Surgery
Applicant
EASTGATE TRADING CORP.
990 AVE. OF AMERICAS, #15D
NEW YORK, NY 10084 US
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MORRIS CORN
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Regulation Number
876.1500
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Classification Product Code
GCJ
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Date Received
03/05/1999
Decision Date
05/19/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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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