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510(k) K943017

NEONATAL RESTRAINT AND COMFORT SYSTEMS by K.Bowmed, Inc. — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1995
Date Received
June 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

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