JAMES ALEX SUNGLASSES— 510(k) K970101
Substantially EquivalentD&K Stores, Inc.
FDA 510(k) clearance K970101 for JAMES ALEX SUNGLASSES, Substantially Equivalent on 1997-03-04. Applicant: D&K Stores, Inc.. Device class: 1.
Clearance details
- Applicant
- D&K Stores, Inc.
- Product code
- Code HQY
- Device class
- Class 1
- Regulation
- 21 CFR 886.5850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakhurst, NJ, US
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