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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 K082156
Device Name ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
Applicant
Teleflex Medical
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact Angela Bouse
Correspondent
Teleflex Medical
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact Angela Bouse
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/30/2008
Decision Date 09/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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