The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Introducer Kits.
| Device ID | K080253 |
| 510k Number | K080253 |
| Device Name: | KIMBERLY-CLARK INTRODUCER KITS |
| Classification | Tube, Gastro-enterostomy |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Sherry Saurini |
| Correspondent | Sherry Saurini KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-02-26 |
| Summary: | summary |