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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K913388
Device Name THE PAN.OPTX SPORTGLASS
Applicant
Panoptx, Inc.
13833 N. 108th Dr.
Sun City,  AZ  85351
Applicant Contact RUSSELL C PARKER
Correspondent
Panoptx, Inc.
13833 N. 108th Dr.
Sun City,  AZ  85351
Correspondent Contact RUSSELL C PARKER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/29/1991
Decision Date 10/02/1991
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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