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FDA 510(k) Application Details - K012644
Device Classification Name
Laparoscope, General & Plastic Surgery, Reprocessed
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510(K) Number
K012644
Device Name
Laparoscope, General & Plastic Surgery, Reprocessed
Applicant
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
3636 E COLUMBINE DR.
PHOENIX, AZ 85032-5655 US
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Contact
ROBERT S MCQUATE
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Regulation Number
876.1500
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Classification Product Code
NLM
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More FDA Info for this Product Code
Date Received
08/13/2001
Decision Date
07/29/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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