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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K223826
Device Name NanoDrop Lancet
Applicant
Drawbridge Health, Inc.
620 Omni Industrial Blvd.
Summerville,  FL  29486
Applicant Contact Dan McEvoy
Correspondent
Drawbridge Health, Inc.
5949 Amberwood Dr.
Naples,  FL  34110
Correspondent Contact Beth Thompson
Regulation Number878.4850
Classification Product Code
FMK  
Date Received12/21/2022
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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