FDA 510(k) Application Details - K971551

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K971551
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant DUQIAO GLASSES (GROUP) CO. LTD.
279 FUQIAN STREET, DUQIAO
LINHAI, ZHEJIANG CN
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Contact MERRY CHEN
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 04/28/1997
Decision Date 06/04/1997
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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