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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 K882249
Device Name M.I.P. - PUMP
Applicant
Intro-Med, Inc.
P.O. Box 175
Buffalo,  NY  14216
Applicant Contact CARL V GERACE
Correspondent
Intro-Med, Inc.
P.O. Box 175
Buffalo,  NY  14216
Correspondent Contact CARL V GERACE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/31/1988
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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