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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 K050464
Device Name ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
Applicant
ULTI MED, INC.
5353 WAYZATA BLVD., STE 505
MINNEAPOLIS,  MN  55414
Applicant Contact CAROLE STAMP
Correspondent
ULTI MED, INC.
5353 WAYZATA BLVD., STE 505
MINNEAPOLIS,  MN  55414
Correspondent Contact CAROLE STAMP
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/23/2005
Decision Date 05/11/2005
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
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