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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K861960
Device Name ZIMLITE LENS
Applicant
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C.
3-23. 5-CHOME HINODE.
FUKUI-CITY 910
JAPAN,  JP
Applicant Contact TEKEUCHI
Correspondent
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C.
3-23. 5-CHOME HINODE.
FUKUI-CITY 910
JAPAN,  JP
Correspondent Contact TEKEUCHI
Regulation Number886.5844
Classification Product Code
HQG  
Date Received05/20/1986
Decision Date 06/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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