K-number	K834611
Device name	SINGUL-XR RP NON SCREEN MED. FILM
Applicant	Cea America Corp.
Product code	IWZ
Device class	Class I
Decision date	Feb 21, 1984
Decision	Substantially Equivalent
Regulation	892.1840

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View the full FDA submission: accessdata.fda.gov

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SINGUL-XR RP NON SCREEN MED. FILM

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