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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K852051
Device Name EXTERNAL MALE CATHETER
Applicant
Buffalo Medical Specialties Mfg., Inc.
P.O. Box 17247
14205 Myer Lake Cir.
Clearwater,  FL  33520
Applicant Contact HANSEN
Correspondent
Buffalo Medical Specialties Mfg., Inc.
P.O. Box 17247
14205 Myer Lake Cir.
Clearwater,  FL  33520
Correspondent Contact HANSEN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received05/09/1985
Decision Date 08/22/1985
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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