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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K870977
Device Name PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
Applicant
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Applicant Contact LAWRENCE W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
27200 N. Tourney Rd.
Post Office Box 5900
Valencia,  CA  91355
Correspondent Contact LAWRENCE W GETLIN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received03/10/1987
Decision Date 04/01/1987
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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