FDA 510(k) Application Details - K955441

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K955441
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant ZONG RONG GLASSES LTD. CO.
1 FL., NO. 174
CHRONG-SHYUE RD.
TAINAN TW
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 11/21/1995
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



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