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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Bite
510(k) Number K864181
Device Name SOMATICS MOUTH GUARD (BITE BLOCK)
Applicant
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Applicant Contact ABRAMS, M.D.
Correspondent
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Correspondent Contact ABRAMS, M.D.
Regulation Number882.5070
Classification Product Code
JXL  
Date Received10/27/1986
Decision Date 11/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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