Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K212328 |
Device Name |
DiscCath Needle Set |
Applicant |
DiscCath LLC |
62 E 88th Street |
New York,
NY
10128
|
|
Applicant Contact |
Gregory E. Lutz |
Correspondent |
DiscCath LLC |
62 E 88th Street |
New York,
NY
10128
|
|
Correspondent Contact |
Gregory E. Lutz |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 07/27/2021 |
Decision Date | 09/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|