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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 K934858
Device Name FRAME SPECTACLE
Applicant
Arno Intl., Inc.
330 S. State Rd. 7, Suite B
Plantation,  FL  33317
Applicant Contact G. FRANCI
Correspondent
Arno Intl., Inc.
330 S. State Rd. 7, Suite B
Plantation,  FL  33317
Correspondent Contact G. FRANCI
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/12/1993
Decision Date 12/08/1993
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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