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FDA 510(k) Application Details - K030619
Device Classification Name
Washer, Bolt Nut
More FDA Info for this Device
510(K) Number
K030619
Device Name
Washer, Bolt Nut
Applicant
ORTHOPEDIC DESIGNS, INC.
6965 1ST. AVE. NORTH
ST. PETERSBURG, FL 33710-8303 US
Other 510(k) Applications for this Company
Contact
PATRICK J COSGROVE
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HTN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2003
Decision Date
04/01/2003
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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