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FDA 510(k), K001527, FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
FDA 510(k), K001527, FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
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510(K) Number: K001527
Device Name: FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
Manufacturer: MOJCA VALJAVEC
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 05/16/2000
Decision Date: 07/27/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
Manufacturer: MOJCA VALJAVEC
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 05/16/2000
Decision Date: 07/27/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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