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510(k) K933964

THE CRADLE by The Primal Energy Research Foundation — Product Code IKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
August 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Powered
Device Class
Class II
Regulation Number
890.5225
Review Panel
PM
Submission Type

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