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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K861021
Device Name GOTTEX SUNGLASSES
Applicant
Private Eyes Sunglass Corp.
77 Accord Park Dr.
Norwell,  MA  02061
Applicant Contact ELAINE BACKER
Correspondent
Private Eyes Sunglass Corp.
77 Accord Park Dr.
Norwell,  MA  02061
Correspondent Contact ELAINE BACKER
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/18/1986
Decision Date 06/17/1986
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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