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FDA 510(k), K033120, SCALETRON PIEZO ULTRASOUND SCALER
FDA 510(k), K033120, SCALETRON PIEZO ULTRASOUND SCALER
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510(K) Number: K033120
Device Name: SCALETRON PIEZO ULTRASOUND SCALER
Manufacturer: PAC-DENT INTERNATIONAL (SUZHOU), LTD.
Device Classification Name: Scaler, Ultrasonic
Regulation Number: 872.4850
Classification Product Code: ELC
Date Received: 09/30/2003
Decision Date: 01/29/2004
Regulation Medical Specialty: Dental
Device Name: SCALETRON PIEZO ULTRASOUND SCALER
Manufacturer: PAC-DENT INTERNATIONAL (SUZHOU), LTD.
Device Classification Name: Scaler, Ultrasonic
Regulation Number: 872.4850
Classification Product Code: ELC
Date Received: 09/30/2003
Decision Date: 01/29/2004
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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