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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 K912034
Device Name VENETO COLLECTION
Applicant
Atlantic Optical Co., Inc.
20801 Nordhoff St.
P.O. Box 3519
Chatsworth,  CA  91313
Applicant Contact MEL HOFFMAN
Correspondent
Atlantic Optical Co., Inc.
20801 Nordhoff St.
P.O. Box 3519
Chatsworth,  CA  91313
Correspondent Contact MEL HOFFMAN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received05/08/1991
Decision Date 08/22/1991
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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