The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for Mic-key Sf Low Profile Gastrostomy Tube And Accessories.
| Device ID | K122653 |
| 510k Number | K122653 |
| Device Name: | MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE RD. BLDG 300/1 Roswell, GA 30076 |
| Contact | David Lee |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2013-06-26 |
| Summary: | summary |