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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
510(k) Number K881759
Device Name BT-1 INFUSION PUMP
Applicant
Ferring Laboratories, Inc.
75 Montebello Rd.
Suffern,  NY  10901
Applicant Contact DANIEL M LINKIE,PHD
Correspondent
Ferring Laboratories, Inc.
75 Montebello Rd.
Suffern,  NY  10901
Correspondent Contact DANIEL M LINKIE,PHD
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/25/1988
Decision Date 02/28/1989
Decision Substantially Equivalent (SESE)
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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