510(k) K210321
- Device
- Dukal Corporation Level 1 Pediatric Face Mask
- Applicant
- Dukal Corporation
- 510(k) number
- K210321
- Product code
- OXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-29
- Date received
- 2021-02-04
- Regulation
- 878.4040
- Classification name
- Pediatric/Child Facemask
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Megan Quevedo
- Address
- 2 Fleetwood Ct. Ronkonkoma NY US 11779 11779
FDA Registration Numbers
- 3013152643
- 3012421607
- 3017425988
- 3011390041
- 3005022483
- 3014421917
- 9616096
- 3017229009
- 9611959
- 3017949824
- 3005599545
- 9615270
Source Documents
Other 510(k) Records For Product Code OXZ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221753 | Kangbeier Child Surgical Mask | Xinxiang Kangbeier Medical Technology Co., Ltd. | 2023-12-21 |
| K213427 | PRIMED Pediatric Facemask | Primed Medical Products, Inc. | 2022-11-22 |
| K201514 | Child Face Mask | Shandong Shengquan New Material Co., Ltd. | 2021-10-10 |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | 2021-08-26 |
| K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) | Amd Medicom, Inc. | 2019-09-17 |
| K160100 | Prestige Ameritech Pediatric/Childs Face mask | Prestige Ameritech | 2016-10-07 |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Kimberly-Clark | 2011-09-23 |