Name: Predicase
Price: 199 USD

K-number	K935434
Device name	OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
Applicant	United States Surgical, A Division of Tyco Healthc
Product code	LKF
Device class	Class II
Decision date	May 27, 1994
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT

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