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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 K934033
Device Name SPECTACLE FRAMES
Applicant
H.M.O. Optical, Inc.
2 NE 40th St., 3rd Floor
Miami,  FL  33137
Applicant Contact LINDA RAMOS
Correspondent
H.M.O. Optical, Inc.
2 NE 40th St., 3rd Floor
Miami,  FL  33137
Correspondent Contact LINDA RAMOS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/18/1993
Decision Date 10/04/1993
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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