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FDA 510(k) Application Details - K053192
Device Classification Name
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
More FDA Info for this Device
510(K) Number
K053192
Device Name
Walker, Mechanical, Poly Vinyl Chloride (Pvc)
Applicant
MJM INTERNATIONAL CORPORATION
2003 N. I RD., STE. 10
SAN JUAN, TX 78589 US
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Contact
MELLY MOROLES
Other 510(k) Applications for this Contact
Regulation Number
890.3825
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Classification Product Code
NXE
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More FDA Info for this Product Code
Date Received
11/15/2005
Decision Date
12/05/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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