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510(k) K041996

NIGHTFORM by Plastic Surgery Solutions, LLC — Product Code FRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2004
Date Received
July 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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