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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scaler, ultrasonic
510(k) Number K053555
Device Name ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
Original Applicant
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
340 shady grove road
flintville,  TN  37335
Original Contact charlie mack
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/20/2005
Decision Date 08/21/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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