OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
FDA 510(k) clearance K875197 · decided 1988-02-09
Clearance details
- K-number
- K875197
- Device name
- OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE
- Applicant
- Pro-Optics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-17
- Decision date
- 1988-02-09
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- LRX
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.