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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 K952258
Device Name HURRICANE
Applicant
Hurricane Hardware, Inc.
4f, # 6, Aly. 16,
Ln. 235, Pau-Chia Rd.,
Hsin Tien City, Taipei Hsien,  TW R.O.C.
Applicant Contact JEVONS YOUNG
Correspondent
Hurricane Hardware, Inc.
4f, # 6, Aly. 16,
Ln. 235, Pau-Chia Rd.,
Hsin Tien City, Taipei Hsien,  TW R.O.C.
Correspondent Contact JEVONS YOUNG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/15/1995
Decision Date 07/31/1995
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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