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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Enteral
510(k) Number K951429
Device Name FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
Applicant
Ross Products
625 Cleveland Ave.
Columbus,  OH  43215
Applicant Contact MICHAEL H HANEY
Correspondent
Ross Products
625 Cleveland Ave.
Columbus,  OH  43215
Correspondent Contact MICHAEL H HANEY
Regulation Number880.5725
Classification Product Code
LZH  
Date Received03/28/1995
Decision Date 12/22/1995
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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