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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K002127
Device Name INJECTRITE-C15 AND INJECTRITE-C30
Applicant
Sterling Medivations, Inc.
180 Ferndale Rd. S.
Wayzata,  MN  55391
Applicant Contact JOEL DOUGLAS
Correspondent
Sterling Medivations, Inc.
180 Ferndale Rd. S.
Wayzata,  MN  55391
Correspondent Contact JOEL DOUGLAS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/14/2000
Decision Date 12/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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