FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

VICTORY EYEWEAR CO

K Number: K970538 · Decision Mar 25, 1997
Classifications
1
FEI Numbers
1390
Registration Numbers
1390
Same Product Code
645
Applicant Total
2
Review Days
41

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Basic Information

Device Name
VICTORY EYEWEAR CO
K Number
K970538
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.5850
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Victory Eyewear Co., Ltd.
Date Received
February 12, 1997
Decision Date
March 25, 1997
Product Code
HQY
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HQY Sunglasses (Non-Prescription Including Photosensitive)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (HQY), ordered by most recent decision date.

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Other Clearances by Victory Eyewear Co., Ltd.

K Number Device Name
K965021 NON-PRESCRIPTION SUNGLASSES