K-number	K803171
Device name	PROCEDURE & RECOVERY PATIENT SUIT
Applicant	Alba Health Care
Product code	FYB
Device class	Class II
Decision date	Mar 4, 1981
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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PROCEDURE & RECOVERY PATIENT SUIT

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