FDA 510(k) Application Details - K070671

Device Classification Name Endoscopic Tissue Approximation Device

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510(K) Number K070671
Device Name Endoscopic Tissue Approximation Device
Applicant ARTHROCARE CORP.
15285 ALTON PARKWAY, #200
IRVINE, CA 92618 US
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Contact LAURA N KASPEROWICZ
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Regulation Number 876.1500

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Classification Product Code OCW
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Date Received 03/12/2007
Decision Date 04/06/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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