FDA 510(k) Application Details - K954972

Device Classification Name Sound, Metal, Interconnected

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510(K) Number K954972
Device Name Sound, Metal, Interconnected
Applicant VENTURE MANAGEMENT CORP.
2323 CURLEW RD.
SUITE 2-E
PALM HARBOR, FL 34683 US
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Contact GENE ZAMBA
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Regulation Number 876.4590

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Classification Product Code FBS
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Date Received 10/27/1995
Decision Date 01/24/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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