FDA 510(k) Application Details - K973611

Device Classification Name Forceps, Biopsy, Non-Electric

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510(K) Number K973611
Device Name Forceps, Biopsy, Non-Electric
Applicant SPECTRASCIENCE, INC.
3650 ANNAPOLIS LANE, SUITE 101
MINNEAPOLIS, MN 55447-5434 US
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Contact JOHN G YAGER
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Regulation Number 876.1075

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Classification Product Code FCL
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Date Received 09/22/1997
Decision Date 12/02/1997
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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