Name: Predicase
Price: 199 USD

K-number	K210934
Device name	Sphincterotome / short-wire compatible, Sterile Sphincterotome
Applicant	Micro-Tech (Nanjing) Co., Ltd.
Product code	KNS
Device class	Class II
Decision date	Dec 1, 2021
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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Sphincterotome / short-wire compatible, Sterile Sphincterotome

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