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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 K082218
Device Name MAX ADJUSTING INSTRUMENT
Applicant
Manna Omni International, Inc.
340 E. Commonwealth Ave.
Fullerton,  CA  92832
Applicant Contact STEPHEN TSAI
Correspondent
Manna Omni International, Inc.
340 E. Commonwealth Ave.
Fullerton,  CA  92832
Correspondent Contact STEPHEN TSAI
Classification Product Code
LXM  
Date Received08/06/2008
Decision Date 08/13/2008
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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