FDA 510(k) Application Details - K964871

Device Classification Name Accessories, Cleaning, For Endoscope

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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
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Regulation Number 876.1500

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Classification Product Code FEB
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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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