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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 K961603
Device Name SUN CLIP
Applicant
Intromark, Inc.
217 Ninth St.
Pittsburgh,  PA  15222 -3506
Applicant Contact CHRISTOPHER ROSLECK
Correspondent
Intromark, Inc.
217 Ninth St.
Pittsburgh,  PA  15222 -3506
Correspondent Contact CHRISTOPHER ROSLECK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/25/1996
Decision Date 05/13/1996
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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