Name: Predicase
Price: 199 USD

K-number	K200320
Device name	Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
Applicant	M/s. Meril Endo Surgery Private Limited.
Product code	GDW
Device class	Class II
Decision date	Feb 5, 2021
Decision	Substantially Equivalent
Regulation	878.4750

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

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