FDA 510(k) Application Details - K060076

Device Classification Name Counter, Sponge, Surgical

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510(K) Number K060076
Device Name Counter, Sponge, Surgical
Applicant SURGICOUNT MEDICAL
5582 CHALON ROAD
YORBA LINDA, CA 92886 US
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Contact SHARON ROCKWELL
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Regulation Number 880.2740

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Classification Product Code LWH
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Date Received 01/10/2006
Decision Date 03/14/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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