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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ink, Arch Tracing
510(k) Number K810972
Device Name THE GNATHOMETER-M
Applicant
BAUER, CHENG & ASSOCIATES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BAUER, CHENG & ASSOCIATES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3150
Classification Product Code
KZO  
Date Received04/09/1981
Decision Date 05/05/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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