Name: Predicase
Price: 199 USD

K-number	K242208
Device name	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Applicant	Primed Medical Products, Inc.
Product code	FRG
Device class	Class II
Decision date	Oct 7, 2024
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

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