Name: Predicase
Price: 199 USD

K-number	K880588
Device name	AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4
Applicant	C.I.S.A. Import Export C/O Larson and Taylor
Product code	HIB
Device class	Class II
Decision date	Dec 20, 1988
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4

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