The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Kc100 Surgical Gown, Model Kc100.
| Device ID | K093115 |
| 510k Number | K093115 |
| Device Name: | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Marcia Johnson |
| Correspondent | Marcia Johnson KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651792953 | K093115 | 000 |
| 30680651792946 | K093115 | 000 |
| 30680651792854 | K093115 | 000 |
| 30680651792847 | K093115 | 000 |
| 30680651992858 | K093115 | 000 |
| 30680651992841 | K093115 | 000 |
| 30680651451843 | K093115 | 000 |
| 30680651451836 | K093115 | 000 |