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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
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Guilin Woodpecker Medical Instrument Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Correspondent Contact CHARLIE MACK
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/20/2005
Decision Date 08/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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