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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 K933809
Device Name OPTO LINE SRL
Applicant
OPTOLINE S.R.L.
VIA DELLA CENTA
34 - Z.I. 31040
SEGUSINO (TV),  IT
Applicant Contact ADAMI GILBERTO
Correspondent
OPTOLINE S.R.L.
VIA DELLA CENTA
34 - Z.I. 31040
SEGUSINO (TV),  IT
Correspondent Contact ADAMI GILBERTO
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/04/1993
Decision Date 10/18/1993
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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