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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 K870165
Device Name FOLEY CATHETER
Applicant
Acorn Medical Products
1036 Cowper St.
Palo Alto,  CA  94301
Applicant Contact JAMES P STOUT
Correspondent
Acorn Medical Products
1036 Cowper St.
Palo Alto,  CA  94301
Correspondent Contact JAMES P STOUT
Regulation Number876.5130
Classification Product Code
KOD  
Date Received01/14/1987
Decision Date 04/17/1987
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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