INTEGRE PRO, MODEL L2RY
FDA 510(k) clearance K081565 · decided 2008-07-02
Clearance details
- K-number
- K081565
- Device name
- INTEGRE PRO, MODEL L2RY
- Applicant
- Ellex Medical Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-04
- Decision date
- 2008-07-02
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Adelaide, South Australia, AU
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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