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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 K935541
Device Name SUNGLASSES
Applicant
Seven Pyramid Ent Co., Ltd.
Office #4, Aly. 14, Ln. 333
Hsin-Ming Rd.
Taipei 11413, Taiwan, R.O.C.,  TW
Applicant Contact SAM HO
Correspondent
Seven Pyramid Ent Co., Ltd.
Office #4, Aly. 14, Ln. 333
Hsin-Ming Rd.
Taipei 11413, Taiwan, R.O.C.,  TW
Correspondent Contact SAM HO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/16/1993
Decision Date 01/06/1994
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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