510(k) K182766
- Device
- Cufitec Surgical Mask
- Applicant
- NBC Meshtec Inc.
- 510(k) number
- K182766
- Product code
- OUK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-03
- Date received
- 2018-09-28
- Regulation
- 878.4040
- Classification name
- Surgical Mask With Antimicrobial/antiviral Agent
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tomokazu Nagao
- Address
- 2-50-3 Toyoda Hino JP 191-0053 191-0053
FDA Registration Numbers#
- 3013152643
- 3003495693
- 3005022483
Source Documents#
Other 510(k) Records For Product Code OUK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231741 | ProGear® Surgical Mask with Oxafence®, Model AV82030 | Prestige Ameritech | 2024-09-05 |
| K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | 2019-11-29 |
| K101128 | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 | Filligent Limited | 2011-05-26 |
Legacy Summary#
summary
FDA Review#
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