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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 K203792
Device Name Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Applicant
Pikdare Spa
Via Saldarini Catelli 10
Casnate Con Bernate,  IT 22070
Applicant Contact Roberta Zanoni
Correspondent
Pikdare Spa
Via Saldarini Catelli 10
Casnate Con Bernate,  IT 22070
Correspondent Contact Roberta Zanoni
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/28/2020
Decision Date 01/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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