Name: Predicase
Price: 199 USD

K-number	K970377
Device name	PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
Applicant	Plancon Instruments
Product code	HNO
Device class	Class I
Decision date	Mar 31, 1997
Decision	Substantially Equivalent
Regulation	886.4370

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Source

View the full FDA submission: accessdata.fda.gov

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PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)

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