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FDA 510(k) Application Details - K980123
Device Classification Name
Laparoscope, General & Plastic Surgery
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510(K) Number
K980123
Device Name
Laparoscope, General & Plastic Surgery
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE, KY 40217-1865 US
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Contact
MARK STERRETT
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
GCJ
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More FDA Info for this Product Code
Date Received
01/14/1998
Decision Date
03/09/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
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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