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FDA 510(k) Application Details - K981822
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
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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DAVID WILLIAMS
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
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More FDA Info for this Product Code
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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