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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Biliary Mechanical
510(k) Number K860863
Device Name ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER
Applicant
George Percy Mcgown
300 SW 70 Ter.
Pembroke Pines,  FL  33023
Correspondent
George Percy Mcgown
300 SW 70 Ter.
Pembroke Pines,  FL  33023
Regulation Number876.4500
Classification Product Code
LQC  
Date Received03/07/1986
Decision Date 05/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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