FDA 510(k) Application Details - K962725

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K962725
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant SOMA INTERNATIONAL LTD.
75 MODY ROAD, TST EAST
KOWLOON HK
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Contact B. K. MA
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 07/15/1996
Decision Date 07/25/1996
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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