Name: Predicase
Price: 199 USD

K-number	K211571
Device name	Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Applicant	Zhejiang Longterm Medical Technology Co., Ltd.
Product code	OMP
Device class	Class II
Decision date	May 31, 2022
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

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