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FDA 510(k) Application Details - K052802
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K052802
Device Name
Instrument, Biopsy
Applicant
MANAN MEDICAL PRODUCTS, INC.
241 WEST PALATINE RD.
WHEELING, IL 60090 US
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Contact
NICOHL R WILDING
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
11/01/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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