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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 K151090
Device Name CPL Insulin Pen Needle
Applicant
Cpl Co., Ltd.
36, Yongteurim-Gil, Danwon-Gu
Ansan,  KR 425-430
Applicant Contact CHOI KYOUNG SOO
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/23/2015
Decision Date 09/21/2016
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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