FDA 510(k) Application Details - K962239

Device Classification Name Manipulator, Plunger-Like Joint

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510(K) Number K962239
Device Name Manipulator, Plunger-Like Joint
Applicant SIGMA
175 WILLIAM PITT WAY
PITTSBURGH, PA 15238 US
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Contact TAMAS BECSE
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Regulation Number 000.0000

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Classification Product Code LXM
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Date Received 06/11/1996
Decision Date 01/10/1997
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

FDA Source Information for K962239


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