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FDA 510(k), K023213, RDH-2000
FDA 510(k), K023213, RDH-2000
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510(K) Number: K023213
Device Name: RDH-2000
Manufacturer: THAD OVERMYER
Device Classification Name: Unit, Operative Dental
Regulation Number: EIA
Classification Product Code: KXA
Date Received: 09/26/2002
Decision Date: 01/16/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: RDH-2000
Manufacturer: THAD OVERMYER
Device Classification Name: Unit, Operative Dental
Regulation Number: EIA
Classification Product Code: KXA
Date Received: 09/26/2002
Decision Date: 01/16/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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