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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscopic single port access device
510(k) Number K121309
Model WA58010Q
Device Name ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
Original Applicant
ADVANCED SURGICAL CONCEPTS
355 thirteenth street, nw
columbia square
washington,  DC  20004
Original Contact jonathan kahan
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received05/01/2012
Decision Date 09/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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