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FDA 510(k) Application Details - K060076
Device Classification Name
Counter, Sponge, Surgical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.2740
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Classification Product Code
LWH
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More FDA Info for this Product Code
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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