FDA 510(k) Application Details - K963517

Device Classification Name Forceps, Biopsy, Non-Electric

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510(K) Number K963517
Device Name Forceps, Biopsy, Non-Electric
Applicant SPECTRASCIENCE, INC.
5909 BAKER ROAD, SUITE 580
MINNETONKA, MN 55345 US
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Contact BRIAN MCMAHON
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Regulation Number 876.1075

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Classification Product Code FCL
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Date Received 09/03/1996
Decision Date 12/02/1996
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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