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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K041184
Device Name NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
Applicant
Nti-Tss, Inc.
5327 La Glorieta Po Bx 2145
Rancho Santa Fe,  CA  92067
Applicant Contact JAMES BOYD
Correspondent
Nti-Tss, Inc.
5327 La Glorieta Po Bx 2145
Rancho Santa Fe,  CA  92067
Correspondent Contact JAMES BOYD
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/06/2004
Decision Date 05/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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