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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer Reprocessing System
510(k) Number K884154
Device Name TRANSLUMINAL ENDARTERECTOMY DEVICE
Applicant
Thomas J. Fogarty, M.D.
770 Welch Rd.
Suite 216
Palo Alto,  CA  94304
Applicant Contact SHELLY Y MONFORT
Correspondent
Thomas J. Fogarty, M.D.
770 Welch Rd.
Suite 216
Palo Alto,  CA  94304
Correspondent Contact SHELLY Y MONFORT
Regulation Number876.5820
Classification Product Code
LIF  
Date Received10/03/1988
Decision Date 12/27/1988
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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