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FDA 510(k) Application Details - K070059
Device Classification Name
Laparoscope, General & Plastic Surgery, Reprocessed
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510(K) Number
K070059
Device Name
Laparoscope, General & Plastic Surgery, Reprocessed
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
Other 510(k) Applications for this Company
Contact
MOIRA BARTON
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NLM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2007
Decision Date
10/02/2007
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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