FDA 510(k) Application Details - K961523

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K961523
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant DORDA TOYS
2546 CORPORATE PLACE
SUITE B103
MONTEREY PARK, CA 91754 US
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Contact MAY WONG
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 04/22/1996
Decision Date 05/13/1996
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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