The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Microcool Breathable High Performance Surgical Gowns.
| Device ID | K103406 |
| 510k Number | K103406 |
| Device Name: | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. BLDG 300, #1093 Roswell, GA 30076 -2199 |
| Contact | David M Lee |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2010-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651730412 | K103406 | 000 |
| 30680651923234 | K103406 | 000 |
| 30680651923210 | K103406 | 000 |
| 30680651923203 | K103406 | 000 |
| 30680651920424 | K103406 | 000 |
| 30680651920387 | K103406 | 000 |
| 30680651410048 | K103406 | 000 |
| 30680651410000 | K103406 | 000 |
| 30680651409981 | K103406 | 000 |
| 30680651409899 | K103406 | 000 |
| 30680651397172 | K103406 | 000 |
| 30680651397165 | K103406 | 000 |
| 30680651354335 | K103406 | 000 |
| 30680651134173 | K103406 | 000 |
| 30680651133596 | K103406 | 000 |
| 30680651105661 | K103406 | 000 |
| 30680651105586 | K103406 | 000 |
| 30680651923302 | K103406 | 000 |
| 30680651923319 | K103406 | 000 |
| 30680651923333 | K103406 | 000 |
| 30680651730382 | K103406 | 000 |
| 30680651724572 | K103406 | 000 |
| 30680651724541 | K103406 | 000 |
| 30680651724534 | K103406 | 000 |
| 30680651724510 | K103406 | 000 |
| 30680651923586 | K103406 | 000 |
| 30680651923579 | K103406 | 000 |
| 30680651923555 | K103406 | 000 |
| 30680651923548 | K103406 | 000 |
| 30680651923531 | K103406 | 000 |
| 30680651923517 | K103406 | 000 |
| 30680651923470 | K103406 | 000 |
| 30680651923449 | K103406 | 000 |
| 30680651923425 | K103406 | 000 |
| 30680651923401 | K103406 | 000 |
| 30680651923388 | K103406 | 000 |
| 30680651105500 | K103406 | 000 |