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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 K950245
Device Name UNIQUE NEEDLE
Applicant
UNIQUE MANAGEMENT ENT., INC.
209 SCHOOLHOUSE RD.
ALBANY,  NY  12203 -5956
Applicant Contact THOMNAS E FERARI
Correspondent
UNIQUE MANAGEMENT ENT., INC.
209 SCHOOLHOUSE RD.
ALBANY,  NY  12203 -5956
Correspondent Contact THOMNAS E FERARI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/20/1995
Decision Date 12/06/1995
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
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