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510(k) K972176

HOME CARE BEAD BED by Kinetic Concepts, Inc. — Product Code INX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1998
Date Received
June 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

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