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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 K973526
Device Name SUNGLASSES
Applicant
Pyramid Handbags, Inc.
100 W. 33rd St., Suite 800
New York,  NY  10001
Applicant Contact JENNIFER EPSTEIN
Correspondent
Pyramid Handbags, Inc.
100 W. 33rd St., Suite 800
New York,  NY  10001
Correspondent Contact JENNIFER EPSTEIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/18/1997
Decision Date 10/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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