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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K121380
Model 40511R,405910R,405912R
Device Name WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
Original Applicant
TELEFLEX MEDICAL, INC.
2917 weck dr.
research triangle park,  NC  27709
Original Contact natalie smith
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/08/2012
Decision Date 05/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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