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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 K924333
Device Name THE DAVIS DISPOSABLE PROTECTIVE SPLINT
Applicant
Ora-Gard, Inc.
P.O. Box 50303
Knoxville,  TN  37950
Applicant Contact MIKE MILNER
Correspondent
Ora-Gard, Inc.
P.O. Box 50303
Knoxville,  TN  37950
Correspondent Contact MIKE MILNER
Regulation Number882.5070
Classification Product Code
JXL  
Date Received08/27/1992
Decision Date 04/23/1993
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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