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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 K172978
Device Name SurgeoBite
Applicant
Surgovations, LLC
110 Fairway Run
Forsyth,  GA  31029
Applicant Contact Chris Menard
Correspondent
Regulatory Resources Group, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact Julie Stephens
Regulation Number882.5070
Classification Product Code
JXL  
Date Received09/27/2017
Decision Date 12/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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