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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 K952794
Device Name HARVARD 2 SYRINGE PUMP
Applicant
Harvard Apparatus, Inc.
22 Pleasant St.
South Natick,  MA  01760
Applicant Contact ERIC FLACHBART
Correspondent
Harvard Apparatus, Inc.
22 Pleasant St.
South Natick,  MA  01760
Correspondent Contact ERIC FLACHBART
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/19/1995
Decision Date 09/15/1995
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
Recalls CDRH Recalls
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