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FDA 510(k) Application Details - K990231
Device Classification Name
Forceps, Biopsy, Electric
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510(K) Number
K990231
Device Name
Forceps, Biopsy, Electric
Applicant
WILTEK MEDICAL, INC.
101 NORTH CHESTNUT ST., #300
WINSTON-SALEM, NC 27101 US
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Contact
JON S WILSON
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Regulation Number
876.4300
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Classification Product Code
KGE
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More FDA Info for this Product Code
Date Received
01/25/1999
Decision Date
04/13/1999
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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