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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 K844401
Device Name REPRO-MED SYSTEMS INFUSION DEVICE
Applicant
Repro-Med Systems, Inc.
P.O. Box 191
713 N. St.
Middletown,  NY  10940
Applicant Contact ANDREW I SEALFON
Correspondent
Repro-Med Systems, Inc.
P.O. Box 191
713 N. St.
Middletown,  NY  10940
Correspondent Contact ANDREW I SEALFON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/13/1984
Decision Date 03/12/1985
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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