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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 K170988
Device Name DropSafe Safety Pen Needle
Applicant
Htl-Strefa S.A
Adamowek 7
Ozorkow,  PL 95-035
Applicant Contact Aleksandra Prazmowska-Wilanowska
Correspondent
Htl-Strefa S.A
Adamowek 7
Ozorkow,  PL 95-035
Correspondent Contact Aleksandra Prazmowska-Wilanowska
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/03/2017
Decision Date 12/12/2017
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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