The following data is part of a premarket notification filed by The Otc Lab Healthcare B.v. with the FDA for Dr. Yglo Wart Remover.
| Device ID | K210529 |
| 510k Number | K210529 |
| Device Name: | Dr. Yglo Wart Remover |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | The OTC Lab Healthcare B.V. Fred. Roeskestraat 115 Amsterdam, NL 1076ee |
| Contact | Albert Swane |
| Correspondent | Kathleen Johnson Medical Device Approvals, Inc. 104 E. Harrison Ave. Fairfield, IA 52556 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-23 |
| Decision Date | 2021-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00194346121694 | K210529 | 000 |