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FDA 510(k) Application Details - K971275
Device Classification Name
Snare, Flexible
More FDA Info for this Device
510(K) Number
K971275
Device Name
Snare, Flexible
Applicant
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR, OH 44060-4885 US
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Contact
ALAN C POJE
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
FDI
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More FDA Info for this Product Code
Date Received
04/07/1997
Decision Date
05/23/1997
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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