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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K080317
Device Name ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
Applicant
Syntheon, LLC
7290 SW 42nd St.
Miami,  FL  33155
Applicant Contact AL WEISENBORN
Correspondent
Syntheon, LLC
7290 SW 42nd St.
Miami,  FL  33155
Correspondent Contact AL WEISENBORN
Regulation Number876.1500
Classification Product Code
FDF  
Date Received02/06/2008
Decision Date 04/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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