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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K050428
Device Name TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
Applicant
Advanced Spinal Technologies, Inc.
433 Plz. Real, Suite 255
Boca Raton,  FL  33432
Applicant Contact JEFFREY R PERELMAN
Correspondent
Advanced Spinal Technologies, Inc.
433 Plz. Real, Suite 255
Boca Raton,  FL  33432
Correspondent Contact JEFFREY R PERELMAN
Classification Product Code
LXM  
Date Received02/18/2005
Decision Date 06/14/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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