Name: Predicase
Price: 199 USD

K-number	K070964
Device name	KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
Applicant	Welch Allyn, Inc.
Product code	HIB
Device class	Class II
Decision date	May 18, 2007
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM

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