Name: Predicase
Price: 199 USD

K-number	K100537
Device name	REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Applicant	Ascent Healthcare Solutions
Product code	NLQ
Device class	Class U
Decision date	May 12, 2010
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE

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