Device Classification Name |
rongeur, manual
|
510(k) Number |
K200383 |
Device Name |
Wiggins Medical Surgical Instruments |
Applicant |
Wiggins Medical |
2230 Park Avenue #202 |
Cincinnati,
OH
45206
|
|
Applicant Contact |
Alex Ebner |
Correspondent |
JALEX Medical |
27865 Clemens Rd Suite 3 |
Westlake,
OH
44145
|
|
Correspondent Contact |
Cassandra Petrov |
Regulation Number | 882.4840
|
Classification Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 07/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|