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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 K063457
Device Name TRUEHD (1080P) DIGITAL CAMERA SYSTEM
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact ELIZABETH PAUL
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact ELIZABETH PAUL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/15/2006
Decision Date 12/05/2006
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
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