Name: Predicase
Price: 199 USD

K-number	K183263
Device name	UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
Applicant	Unipack Medical Corporation
Product code	PEM
Device class	Class II
Decision date	Jun 14, 2019
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

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