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FDA 510(k) Application Details - K954148
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K954148
Device Name
Washer, Bolt Nut
Applicant
ACUMED, INC.
10950 S.W. 5TH ST.
SUITE 170
BEAVERTON, OR 97005 US
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Contact
SHARI L JEFFERS
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
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More FDA Info for this Product Code
Date Received
09/05/1995
Decision Date
01/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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