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FDA 510(k) Application Details - K964871
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
510(K) Number
K964871
Device Name
Accessories, Cleaning, For Endoscope
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
P.O. BOX 1700
35 INDUSTRIAL PARKWAY
SOMERVILLE, NJ 08876 US
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Contact
ROLAN SOUBRA
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FEB
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More FDA Info for this Product Code
Date Received
12/05/1996
Decision Date
03/03/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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