K-number	K950429
Device name	VIDEO SIGMOIDOSCOPE
Applicant	Welch Allyn, Inc.
Product code	FAM
Device class	Class II
Decision date	Aug 1, 1995
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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VIDEO SIGMOIDOSCOPE

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