OPTI PADS
FDA 510(k) clearance K950940 · decided 1995-06-26
Clearance details
- K-number
- K950940
- Device name
- OPTI PADS
- Applicant
- Karlen Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-27
- Decision date
- 1995-06-26
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LYL
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Charles, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.