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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 St., Ct. 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
Predetermined Change
Control Plan Authorized		 No
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