PLASTIC OR GLASS MAGNIFIER
FDA 510(k) clearance K820375 · decided 1982-06-14
Clearance details
- K-number
- K820375
- Device name
- PLASTIC OR GLASS MAGNIFIER
- Applicant
- Gazelle Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-09
- Decision date
- 1982-06-14
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- HJF
- Device class
- 1
- Regulation number
- 886.5540
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.