Name: Predicase
Price: 199 USD

K-number	K963344
Device name	DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
Applicant	Vision-Sciences, Inc.
Product code	FAM
Device class	Class II
Decision date	Nov 21, 1996
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE

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