510(k) K200624

Device
Percutaneous Introducer
Applicant
Epimed International, Inc.
510(k) number
K200624
Product code
BSO
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-27
Date received
2020-03-10
Regulation
868.5120
Classification name
Catheter, Conduction, Anesthetic
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Related Records

Applicant Contact

Contact
Preston Frasier
Address
13958 Diplomat Dr. Farmers Branch TX US 75234 75234

FDA Registration Numbers

Source Documents

510(k) summary PDF

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