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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pneumoperitoneum needle
510(k) Number K121370
Model AIG2 120, AIG2, 150
Device Name VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
Original Applicant
VECTEC
2995 steven martin dr.
fairfax,  VA  22031
Original Contact diane horwitz
Regulation Number876.1500
Classification Product Code
FHO  
Subsequent Product Codes
FHP   HIF  
Date Received05/07/2012
Decision Date 08/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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