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 |