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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Walker, Mechanical, Poly Vinyl Chloride (Pvc)
510(k) Number K053192
Device Name MODEL 418 SERIES WALKERS
Applicant
Mjm International Corporation
2003 N. I Rd., Suite 10
San Juan,  TX  78589
Applicant Contact MELLY MOROLES
Correspondent
Mjm International Corporation
2003 N. I Rd., Suite 10
San Juan,  TX  78589
Correspondent Contact MELLY MOROLES
Regulation Number890.3825
Classification Product Code
NXE  
Date Received11/15/2005
Decision Date 12/05/2005
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
Predetermined Change
Control Plan Authorized		 No
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