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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 K221783
Device Name SafetiCET Safety Lancet
Applicant
Nsp Tech Pte, Ltd.
10 Admiralty St., Northlink Bldg., #02-06
Singapore,  SG 757695
Applicant Contact HC Tan
Correspondent
Nsp Tech Pte, Ltd.
10 Admiralty St., Northlink Bldg., #02-06
Singapore,  SG 757695
Correspondent Contact HC Tan
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/21/2022
Decision Date 10/24/2022
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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