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FDA 510(k), K081858, RETCAM 3 OPHTHALMIC IMAGING SYSTEM
FDA 510(k), K081858, RETCAM 3 OPHTHALMIC IMAGING SYSTEM
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510(K) Number: K081858
Device Name: RETCAM 3 OPHTHALMIC IMAGING SYSTEM
Manufacturer: CLARITY MEDICAL SYSTEMS
Device Classification Name: camera, ophthalmic, ac-powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 07/01/2008
Decision Date: 11/05/2008
Regulation Medical Specialty: Ophthalmic
Device Name: RETCAM 3 OPHTHALMIC IMAGING SYSTEM
Manufacturer: CLARITY MEDICAL SYSTEMS
Device Classification Name: camera, ophthalmic, ac-powered
Regulation Number: 886.1120
Classification Product Code: HKI
Date Received: 07/01/2008
Decision Date: 11/05/2008
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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