FDA 510(k) Application Details - K971275

Device Classification Name Snare, Flexible

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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
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Regulation Number 876.4300

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Classification Product Code FDI
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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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