FDA 510(k) Application Details - K030619

Device Classification Name Washer, Bolt Nut

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510(K) Number K030619
Device Name Washer, Bolt Nut
Applicant ORTHOPEDIC DESIGNS, INC.
6965 1ST. AVE. NORTH
ST. PETERSBURG, FL 33710-8303 US
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Contact PATRICK J COSGROVE
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Regulation Number 888.3030

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Classification Product Code HTN
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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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