The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kimberly-clark Child's Facemask.
| Device ID | K113340 |
| 510k Number | K113340 |
| Device Name: | KIMBERLY-CLARK CHILD'S FACEMASK |
| Classification | Pediatric/child Facemask |
| Applicant | KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD 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 | 2011-11-14 |
| Decision Date | 2012-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651471926 | K113340 | 000 |
| 30680651473593 | K113340 | 000 |