FDA 510(k) Application Details - K981822

Device Classification Name Equipment, Traction, Powered

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510(K) Number K981822
Device Name Equipment, Traction, Powered
Applicant PROFESSIONAL DISTRIBUTION SYSTEMS, INC.
1160 SOUTH ROGERS CIRCLE, #A
BOCA RATON, FL 33487 US
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Contact DAVID WILLIAMS
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 05/22/1998
Decision Date 06/24/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K981822


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