FDA 510(k) Application Details - K955287

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K955287
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant YUU YENG ENTERPRISE CO., LTD.
1ST FL. NO. 174,
CHUNG HSUEH RD.
TAINAN 510850 TW
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Contact CHI-TSUNG SHIH
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 11/17/1995
Decision Date 01/29/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K955287


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