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FDA 510(k), K090633, LENSAR LASER SYSTEM
FDA 510(k), K090633, LENSAR LASER SYSTEM
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510(K) Number: K090633
Device Name: LENSAR LASER SYSTEM
Manufacturer: LENSAR, INC.
Device Classification Name: ophthalmic femtosecond laser
Regulation Number: 886.4390
Classification Product Code: OOE
Date Received: 03/09/2009
Decision Date: 05/13/2010
Regulation Medical Specialty: Ophthalmic
Device Name: LENSAR LASER SYSTEM
Manufacturer: LENSAR, INC.
Device Classification Name: ophthalmic femtosecond laser
Regulation Number: 886.4390
Classification Product Code: OOE
Date Received: 03/09/2009
Decision Date: 05/13/2010
Regulation Medical Specialty: Ophthalmic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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