K-number	K813356
Device name	DEVICE FOR REPOSITIONING A BET PATIENT
Applicant	Ali-Oop Co., Inc.
Product code	FNJ
Device class	Class I
Decision date	Feb 10, 1982
Decision	Substantially Equivalent
Regulation	880.5120

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Source

View the full FDA submission: accessdata.fda.gov

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DEVICE FOR REPOSITIONING A BET PATIENT

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