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FDA 510(k) Application Details - K962850
Device Classification Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
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510(K) Number
K962850
Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Applicant
ETHOX CORP.
251 SENECA ST.
BUFFALO, NY 14204 US
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Contact
JOHN A YOUNG
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Regulation Number
876.5980
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Classification Product Code
KDH
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Date Received
07/22/1996
Decision Date
02/21/1997
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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