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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 K842187
Device Name MULTIPLE LENS, SPECTACLES, CUSTOM
Applicant
Pavuna , Ltd.
1204-5 Champion Bldg.
301-309 Nathan Rd.
Applicant Contact JIMMY LAM
Correspondent
Pavuna , Ltd.
1204-5 Champion Bldg.
301-309 Nathan Rd.
Correspondent Contact JIMMY LAM
Regulation Number886.5844
Classification Product Code
HQG  
Date Received06/04/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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