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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, traction, non-powered
510(k) Number K162702
Device Name Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table
Applicant
STL International, Inc.
9902 162nd Street, Court E
puyallup,  WA  98375
Applicant Contact rylie teeter leier
Correspondent
KARA & Associates
6965 El Camino Real
Suite 105-428
carlsbad,  CA  92009
Correspondent Contact korina a. akhondzadeh
Regulation Number888.5850
Classification Product Code
HST  
Date Received09/28/2016
Decision Date 12/30/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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