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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, contra- and right-angle attachment, dental
510(k) Number K100192
Device Name STRONG DENTAL HANDPIECES
Applicant
SAESHIN PRECISION CO., LTD.
#93-15, PAHO-DONG, DALSEO-GU
DAEGU,  KR 704-220
Applicant Contact Y.S. LEE
Correspondent
UNDERWRITERS LABORATORIES, INC.
2600 NW LAKE RD.
CAMAS,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number872.4200
Classification Product Code
EGS  
Date Received01/22/2010
Decision Date 02/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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