FDA 510(k) Application Details - K982557

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K982557
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant BARD INTERVENTIONAL PRODUCTS DIV.
129 CONCORD RD.
P.O. BOX 7031
BILLERICA, MA 01821-7031 US
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Contact MARION GORDON
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 07/22/1998
Decision Date 09/10/1998
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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