Name: Predicase
Price: 199 USD

K-number	K904931
Device name	AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
Applicant	United States Surgical, A Division of Tyco Healthc
Product code	GAR
Device class	Class II
Decision date	Jan 29, 1991
Decision	Substantially Equivalent
Regulation	878.5020

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Source

View the full FDA submission: accessdata.fda.gov

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AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*

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