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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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More FDA Info for this Product Code
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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