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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 K062702
Device Name ULTICARE DISPOSABLE SYRINGES AND NEEDLES
Applicant
ULTIMED, INC.
5353 WAYZATA BLVD.
SUITE 505
MINNEAPOLIS,  MN  55416 -1334
Applicant Contact CAROLE STAMP
Correspondent
ULTIMED, INC.
5353 WAYZATA BLVD.
SUITE 505
MINNEAPOLIS,  MN  55416 -1334
Correspondent Contact CAROLE STAMP
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received09/11/2006
Decision Date 11/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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