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FDA 510(k), K050336, OPD-STATION SOFTWARE
FDA 510(k), K050336, OPD-STATION SOFTWARE
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510(K) Number: K050336
Device Name: OPD-STATION SOFTWARE
Manufacturer: CAROL PATTERSON
Device Classification Name: Aberrometer, Ophthalmic
Regulation Number: NCF
Classification Product Code: KXA
Date Received: 02/10/2005
Decision Date: 08/24/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: OPD-STATION SOFTWARE
Manufacturer: CAROL PATTERSON
Device Classification Name: Aberrometer, Ophthalmic
Regulation Number: NCF
Classification Product Code: KXA
Date Received: 02/10/2005
Decision Date: 08/24/2005
Decision: Substantially Equivalent (SESE)
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
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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