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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 K120898
Model 8850XXX
Device Name KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
Original Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills,  IL  60061
Original Contact ron haselhorst
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received03/26/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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