Device Classification Name |
unit, cryosurgical, accessories
|
510(k) Number |
K210529 |
Device Name |
Dr. Yglo Wart Remover |
Applicant |
The OTC Lab Healthcare B.V. |
Fred. Roeskestraat 115 |
Amsterdam,
NL
1076EE
|
|
Applicant Contact |
Albert Swane |
Correspondent |
Medical Device Approvals, Inc. |
104 E. Harrison Ave. |
Fairfield,
IA
52556
|
|
Correspondent Contact |
Kathleen Johnson |
Regulation Number | 878.4350
|
Classification Product Code |
|
Date Received | 02/23/2021 |
Decision Date | 05/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|