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FDA 510(k) Application Details - K964757
Device Classification Name
Catheter, Retention Type, Balloon
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510(K) Number
K964757
Device Name
Catheter, Retention Type, Balloon
Applicant
CONTIMED, INC.
415 VALLEY VIEW TRAIL
HOULTON, WI 54082 US
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Contact
CLAUDE TIHON
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZL
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More FDA Info for this Product Code
Date Received
11/27/1996
Decision Date
06/25/1997
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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