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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 K213407
Device Name UltiCare Disposable Pen Needles
Applicant
UltiMed Incorporated
350 Highway 7, Suite 100
Excelsior,  MN  55331
Applicant Contact Paul Lewis
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/19/2021
Decision Date 12/16/2021
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
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