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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 K121796
Model 405188, 410988, 412988, 4050788S, 45188S
Device Name WECK REUSABLE OBTURATOR
Original Applicant
TELEFLEX MEDICAL, INC.
2917 weck dr.
research triangle park,  NC  27709
Original Contact holly kornegay
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/19/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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