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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K172925
Device Name Contact Lens Case, Model: A-1, B-1
Applicant
P L Overseas Limited
Rm. A 4/F Alexandra Indl. Bldg. Blk.A
1064-1066 Tung Chau W. St.
Cheung Sha Wan,  HK
Applicant Contact Maggie Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center
,Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/25/2017
Decision Date 11/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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