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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bar, Preformed
510(k) Number K934468
Device Name SLIP-ON FIXATION SPLINT (SFS)
Applicant
Gatewood Splints
5200 Meadowcreek Dr., #1118
Dallas,  TX  75248
Applicant Contact JOHN B GATEWOOD
Correspondent
Gatewood Splints
5200 Meadowcreek Dr., #1118
Dallas,  TX  75248
Correspondent Contact JOHN B GATEWOOD
Regulation Number872.3165
Classification Product Code
EHO  
Date Received09/10/1993
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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