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FDA 510(k) Application Details - K974794
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K974794
Device Name
Instrument, Biopsy
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY, CT 06798-0505 US
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Contact
GARY LAMOUREUX
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
12/22/1997
Decision Date
01/23/1998
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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