The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for Kimberly-clark Kim Vent Microcuff Endotracheal Tube For Adults.
Device ID | K113333 |
510k Number | K113333 |
Device Name: | KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS |
Classification | Tube, Tracheal (w/wo Connector) |
Applicant | KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Contact | Marcia Johnson |
Correspondent | Marcia Johnson KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
Product Code | BTR |
CFR Regulation Number | 868.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-14 |
Decision Date | 2012-05-11 |
Summary: | summary |