Name: Predicase
Price: 199 USD

K-number	K183356
Device name	Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Applicant	Weihai Xingtai Packaging Products Co., Ltd.
Product code	FRG
Device class	Class II
Decision date	Aug 19, 2019
Decision	Substantially Equivalent
Regulation	880.6850

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

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