510(k) K103150
- Device
- KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
- Applicant
- KIMBERLY-CLARK
- 510(k) number
- K103150
- Product code
- OXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-23
- Date received
- 2010-10-26
- 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
- ANN WATERHOUSE
- Address
- 1400 Holcomb Bridge Rd. Suite 1154, Bldg. 300 Roswell GA US 30076 30076
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 |
| 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/Child’s Face mask | Prestige Ameritech | 2016-10-07 |
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | Kimberly-Clark | 2012-05-04 |
Legacy Summary#
summary
FDA Review#
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