FDA 510(k) Application Details - K961268

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K961268
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant OAKLEY, INC.
10 HOLLAND
IRVINE, CA 92718 US
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Contact LINK NEWCOMB
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 04/02/1996
Decision Date 04/24/1996
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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