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FDA 510(k), K081565, INTEGRE PRO, MODEL L2RY
FDA 510(k), K081565, INTEGRE PRO, MODEL L2RY
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510(K) Number: K081565
Device Name: INTEGRE PRO, MODEL L2RY
Manufacturer: Ellex Medical Pty. Ltd.
Device Classification Name: laser, ophthalmic
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 06/04/2008
Decision Date: 07/02/2008
Regulation Medical Specialty: Ophthalmic
Device Name: INTEGRE PRO, MODEL L2RY
Manufacturer: Ellex Medical Pty. Ltd.
Device Classification Name: laser, ophthalmic
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 06/04/2008
Decision Date: 07/02/2008
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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