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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 K190962
FOIA Releasable 510(k) K190962
Device Name Bella-mu
Applicant
U-Needle B.V.
De Veldmaat 10
Enschede,  NL 7522 NM
Applicant Contact Gert Veldhuis
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/12/2019
Decision Date 02/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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