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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K901228
Device Name MULTI-STRIP
Applicant
Bellhouse Medical, Inc.
2933 Manning Ave. N.
Lake Elmo,  MN  55042
Applicant Contact JULIA JACKSON
Correspondent
Bellhouse Medical, Inc.
2933 Manning Ave. N.
Lake Elmo,  MN  55042
Correspondent Contact JULIA JACKSON
Regulation Number876.5630
Classification Product Code
FKX  
Date Received03/14/1990
Decision Date 05/07/1990
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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