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FDA 510(k) Application Details - K032669
Device Classification Name
Splint, Denis Brown
More FDA Info for this Device
510(K) Number
K032669
Device Name
Splint, Denis Brown
Applicant
YEOU EIR SHUEN MACHINERY CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY TW
Other 510(k) Applications for this Company
Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
890.3675
More FDA Info for this Regulation Number
Classification Product Code
ITN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2003
Decision Date
11/12/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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