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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K920123
Device Name SPECTACLE FRAMES
Applicant
Po-Le Optiks
15651 Saticoy St.
Van Nuys,  CA  91406
Applicant Contact RICHARD PULFER
Correspondent
Po-Le Optiks
15651 Saticoy St.
Van Nuys,  CA  91406
Correspondent Contact RICHARD PULFER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received01/10/1992
Decision Date 03/06/1992
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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