The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Low Barrier, Astm 2100 Face Masks.
| Device ID | K110455 |
| 510k Number | K110455 |
| Device Name: | KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS |
| Classification | Mask, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Ann Waterhouse |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-15 |
| Decision Date | 2011-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651483882 | K110455 | 000 |