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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 K211634
Device Name Hypodermic Needle-Pro EDGE Safety Device
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Dominique Neisz
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact Dominique Neisz
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Codes
FMF   MEG  
Date Received05/27/2021
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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