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FDA 510(k) Application Details - K961286
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K961286
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
INTL. OPTICAL MFG. CO., LTD.
100-102 KING FUK ST., FLAT C&D
4 FL., TAI KING IND. BLDG.
SAN PO KONG, KOWLOON HK
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Contact
WILLY C.S. YAU
Other 510(k) Applications for this Contact
Regulation Number
886.5850
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Classification Product Code
HQY
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More FDA Info for this Product Code
Date Received
04/03/1996
Decision Date
05/16/1996
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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