The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Microcool Surgical Gown, Breathable High Performance Kc400.
| Device ID | K091357 |
| 510k Number | K091357 |
| Device Name: | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | David M Lee |
| Correspondent | David M Lee KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-08-10 |
| Summary: | summary |