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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K885217
Device Name DISCARD DENTAL EXPLORER
Applicant
Wen Hao, Inc.
201 S. Lake Ave.
Suite 800
Pasadena,  CA  91101
Applicant Contact STEVEN B LEHAT
Correspondent
Wen Hao, Inc.
201 S. Lake Ave.
Suite 800
Pasadena,  CA  91101
Correspondent Contact STEVEN B LEHAT
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received12/19/1988
Decision Date 01/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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