Name: Predicase
Price: 199 USD

K-number	K963999
Device name	AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
Applicant	United States Surgical, A Division of Tyco Healthc
Product code	OCW
Device class	Class II
Decision date	Nov 27, 1996
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE

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