Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K200624 |
Device Name |
Percutaneous Introducer |
Applicant |
Epimed International Inc. |
13958 Diplomat Drive |
Farmers Branch,
TX
75234
|
|
Applicant Contact |
Preston Frasier |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 868.5120
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/10/2020 |
Decision Date | 04/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|