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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 Without An Integral Sharps Injury Prevention Feature
510(k) Number K230759
Device Name SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
Applicant
Bosungmeditech Co., Ltd.
#F, 107 Donghwagongdan-Ro, Munmak-Eup
Wonju,  KR
Applicant Contact Yang Ho Song
Correspondent
Andrew Chun
6300 Old York Rd. Apt. 914,
Philip Murray House
Philadelphia,  PA  19141
Correspondent Contact Andrew Chun
Regulation Number878.4850
Classification Product Code
QRK  
Subsequent Product Code
QRL  
Date Received03/20/2023
Decision Date 06/13/2023
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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