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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 K880857
Device Name SYRINGE PUMP MS2000
Applicant
Smash Ent., Inc.
3585 Lexington Ave. N.
Suite 258
Arden Hills,  MN  55126
Applicant Contact JANET L ZAHN
Correspondent
Smash Ent., Inc.
3585 Lexington Ave. N.
Suite 258
Arden Hills,  MN  55126
Correspondent Contact JANET L ZAHN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/01/1988
Decision Date 09/01/1988
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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