510(k) K162525
- Device
- Oniko Nail Brace
- Applicant
- BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI
- 510(k) number
- K162525
- Product code
- MQZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-25
- Date received
- 2016-09-09
- Regulation
- 510(k) Premarket Notification
- Classification name
- Prosthesis, Nail
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FATMA GULRU ERDOGAN
- Address
- Resit Galip Cad. No: 124/10 Gop Cankaya TR 06700 06700
FDA Registration Numbers#
- 3027728077
Source Documents#
Other 510(k) Records For Product Code MQZ #
Legacy Summary#
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FDA Review#
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