K-number	K041996
Device name	NIGHTFORM
Applicant	Plastic Surgery Solutions, LLC
Product code	FRP
Device class	Class I
Decision date	Aug 3, 2004
Decision	Substantially Equivalent
Regulation	880.5680

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Source

View the full FDA submission: accessdata.fda.gov

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NIGHTFORM

Everything you need for a 510(k) submission. Nothing you don't.