FDA 510(k) Application Details - K060671

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K060671
Device Name Couch, Radiation Therapy, Powered
Applicant WFR/AQUAPLAST CORP.
30 LAWLINS PARK
WYCKOFF, NJ 07481 US
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Contact J. DAMON KIRK
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 03/14/2006
Decision Date 05/04/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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