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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
Predetermined Change
Control Plan Authorized		 No
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