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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Migraine/Tension Headache
510(k) Number K010876
Device Name NTI TENSION SUPPRESSION SYSTEM
Applicant
NTI-TSS, INC.
2303 BLUE SMOKE TRAIL
MISHAWAKA,  IN  46544
Applicant Contact BOB WEBER
Correspondent
NTI-TSS, INC.
2303 BLUE SMOKE TRAIL
MISHAWAKA,  IN  46544
Correspondent Contact BOB WEBER
Classification Product Code
OCO  
Date Received03/23/2001
Decision Date 06/20/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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