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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 K100812
Device Name ULTICARE DISPOSABLE PEN NEEDLES
Applicant
Ultimed, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact MARY BETH HENDERSON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/23/2010
Decision Date 06/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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