Name: Predicase
Price: 199 USD

K-number	K210664
Device name	DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Applicant	Ra Medical Systems,Inc
Product code	PDU
Device class	Class II
Decision date	Jul 27, 2021
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)

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