Name: Predicase
Price: 199 USD

K-number	K211001
Device name	C-Qual M Breastboard; Monarch Overhead Arm Positioner
Applicant	Medtec, Inc. Dba Civco Medical Solutions and Civco
Product code	IYE
Device class	Class II
Decision date	May 20, 2021
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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C-Qual M Breastboard; Monarch Overhead Arm Positioner

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

C-Qual M Breastboard; Monarch Overhead Arm Positioner