510(k) K190308
- Device
- 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
- Applicant
- AMD Medicom, Inc.
- 510(k) number
- K190308
- Product code
- OXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-17
- Date received
- 2019-02-12
- Regulation
- 878.4040
- Classification name
- Pediatric/child Facemask
- 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
- Ronald Reuben
- Address
- 2555 Chemin De L'Aviation, Pt.e-Claire Montreal CA H9P 2Z2 H9P 2Z2
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 |
| K210321 | Dukal Corporation Level 1 Pediatric Face Mask | Dukal Corporation | 2022-03-29 |
| 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 |
| K160100 | Prestige Ameritech Pediatric/Child’s 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 |
Legacy Summary#
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FDA Review#
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