FDA 510(k) Application Details - K062244

Device Classification Name Endoscopic Tissue Approximation Device

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510(K) Number K062244
Device Name Endoscopic Tissue Approximation Device
Applicant ARTHROCARE CORP.
27130 A PASEO ESPADA
SUITE 1427
SAN JUAN CAPISTRANO, CA 92675 US
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Contact LAURA KASPEROWICZ
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Regulation Number 876.1500

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Classification Product Code OCW
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Date Received 08/03/2006
Decision Date 10/02/2006
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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