The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Mic-key Low Profile Gastrostomy Tube.
| Device ID | K043114 |
| 510k Number | K043114 |
| Device Name: | KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | KIMBERLY-CLARK CORP. 12050 LONE PEAK PARKWAY Draper, UT 84020 |
| Contact | S. Mcmillan |
| Correspondent | S. Mcmillan KIMBERLY-CLARK CORP. 12050 LONE PEAK PARKWAY Draper, UT 84020 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-10 |
| Decision Date | 2004-12-10 |