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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K001853
Device Name SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
Applicant
Medtech Systems, Inc.
4825 Olson Memorial Hwy.,
Suite 103
Golden Valley,  MN  55422
Applicant Contact GARY MILLER
Correspondent
Medtech Systems, Inc.
4825 Olson Memorial Hwy.,
Suite 103
Golden Valley,  MN  55422
Correspondent Contact GARY MILLER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/19/2000
Decision Date 08/22/2001
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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