The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Microcuff Pediatric Endotracheal Tube.
| Device ID | K080821 |
| 510k Number | K080821 |
| Device Name: | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Sherri Saurini |
| Correspondent | Sherri Saurini KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10609038351695 | K080821 | 000 |
| 10609038351121 | K080821 | 000 |
| 10609038351138 | K080821 | 000 |
| 10609038351145 | K080821 | 000 |
| 10609038351152 | K080821 | 000 |
| 10609038351169 | K080821 | 000 |
| 10609038351176 | K080821 | 000 |
| 10609038351183 | K080821 | 000 |
| 10609038351190 | K080821 | 000 |
| 10609038351619 | K080821 | 000 |
| 10609038351626 | K080821 | 000 |
| 10609038351633 | K080821 | 000 |
| 10609038351640 | K080821 | 000 |
| 10609038351657 | K080821 | 000 |
| 10609038351664 | K080821 | 000 |
| 10609038351671 | K080821 | 000 |
| 10609038351688 | K080821 | 000 |
| 10609038351114 | K080821 | 000 |