Name: Predicase
Price: 199 USD

K-number	K200253
Device name	Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
Applicant	Ethicon Endo-Surgery
Product code	GEI
Device class	Class II
Decision date	May 27, 2020
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector

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