Name: Predicase
Price: 199 USD

K-number	K960810
Device name	BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
Applicant	Marlo Surgical Technology
Product code	HET
Device class	Class II
Decision date	Oct 21, 1996
Decision	Substantially Equivalent
Regulation	884.1720

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Source

View the full FDA submission: accessdata.fda.gov

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BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM

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