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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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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