The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Gastrointestinal Anchor Set With Saf-t-pexy Fasteners, Enternal Access Dilation System.
| Device ID | K093312 |
| 510k Number | K093312 |
| Device Name: | KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM |
| Classification | Tube, Gastro-enterostomy |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Lester Padilla |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-22 |
| Decision Date | 2009-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10680651987065 | K093312 | 000 |
| 10680651987058 | K093312 | 000 |
| 10680651987041 | K093312 | 000 |
| 10680651987034 | K093312 | 000 |
| 10680651987027 | K093312 | 000 |
| 00350770987019 | K093312 | 000 |
| 10680651987010 | K093312 | 000 |