The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kimberly-clark Child/pediatric Face Mask.
| Device ID | K103150 |
| 510k Number | K103150 |
| Device Name: | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK |
| Classification | Pediatric/child Facemask |
| Applicant | KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD SUITE 1154, BLDG 300 Roswell, GA 30076 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD SUITE 1154, BLDG 300 Roswell, GA 30076 |
| Product Code | OXZ |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-26 |
| Decision Date | 2011-09-23 |
| Summary: | summary |