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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered
510(k) Number K051135
Device Name AXIOM NVP8500
Applicant
AXIOM WORLDWIDE, INC.
9423 CORPORATE LAKE DRIVE
TAMPA,  FL  33634
Applicant Contact JAMES J GIBSON
Correspondent
AXIOM WORLDWIDE, INC.
9423 CORPORATE LAKE DRIVE
TAMPA,  FL  33634
Correspondent Contact JAMES J GIBSON
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GXY   LIH  
Date Received05/03/2005
Decision Date 08/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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