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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
Applicant Contact CAROLE STAMP
Correspondent
Ultimed, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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