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FDA 510(k) Application Details - K970295
Device Classification Name
Bed, Flotation Therapy, Powered
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510(K) Number
K970295
Device Name
Bed, Flotation Therapy, Powered
Applicant
HILL-ROM, INC.
4349 CORPORATE RD.
CHARLESTON, SC 29405 US
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EDWIN BILLS
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Regulation Number
890.5170
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Classification Product Code
IOQ
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Date Received
01/27/1997
Decision Date
05/16/1997
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
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