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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K080600
Device Name ULTIMED ULTICARE SAFETY SYRINGE
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
MEG  
Date Received03/03/2008
Decision Date 06/25/2008
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
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