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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 K252886
Device Name Pen Needle
Applicant
Hh Global Technology, Inc.
6303 Woodlake Dr.
Buford,  GA  30518
Applicant Contact Grace Hammond
Correspondent
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/10/2025
Decision Date 01/06/2026
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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