FDA 510(k) Application Details - K050428

Device Classification Name Manipulator, Plunger-Like Joint

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510(K) Number K050428
Device Name Manipulator, Plunger-Like Joint
Applicant ADVANCED SPINAL TECHNOLOGIES, INC.
433 PLAZA REAL, SUITE 255
BOCA RATON, FL 33432 US
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Contact JEFFREY R PERELMAN
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Regulation Number 000.0000

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Classification Product Code LXM
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Date Received 02/18/2005
Decision Date 06/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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