Name: Predicase
Price: 199 USD

K-number	K023843
Device name	SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE
Applicant	Opus Medical, Inc.
Product code	OCW
Device class	Class II
Decision date	Feb 14, 2003
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

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