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FDA 510(k), K981989, THE WAVE DIGITAL PHACO SYSTEM
FDA 510(k), K981989, THE WAVE DIGITAL PHACO SYSTEM
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510(K) Number: K981989
Device Name: THE WAVE DIGITAL PHACO SYSTEM
Manufacturer: MAURICE IMONTI
Device Classification Name: Unit, Phacofragmentation
Regulation Number: HQC
Classification Product Code: 06/05/1998
Date Received: 08/25/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: THE WAVE DIGITAL PHACO SYSTEM
Manufacturer: MAURICE IMONTI
Device Classification Name: Unit, Phacofragmentation
Regulation Number: HQC
Classification Product Code: 06/05/1998
Date Received: 08/25/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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