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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 K883416
Device Name MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD)
Applicant
SCOTT ALL-SPORTS, INC.
120 PROFESSIONAL DR.
WEST MONROE,  LA  71291 -5389
Applicant Contact SCOTT, DDS
Correspondent
SCOTT ALL-SPORTS, INC.
120 PROFESSIONAL DR.
WEST MONROE,  LA  71291 -5389
Correspondent Contact SCOTT, DDS
Regulation Number882.5070
Classification Product Code
JXL  
Date Received08/15/1988
Decision Date 10/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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