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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K943430
Device Name CERVICAL FUNCTION INDICATOR
Applicant
Whiplash Analysis, Inc.
3714 E. Indian School Rd.
Phoenix,  AZ  85018
Applicant Contact PAUL OSTERBAUER
Correspondent
Whiplash Analysis, Inc.
3714 E. Indian School Rd.
Phoenix,  AZ  85018
Correspondent Contact PAUL OSTERBAUER
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received07/15/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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