Name: Predicase
Price: 199 USD

K-number	K040494
Device name	CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
Applicant	United States Endoscopy Group, Inc.
Product code	NEZ
Device class	Class II
Decision date	Jun 23, 2004
Decision	Substantially Equivalent
Regulation	876.1300

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Source

View the full FDA submission: accessdata.fda.gov

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CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

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