The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Professional Jacket.
| Device ID | K880385 |
| 510k Number | K880385 |
| Device Name: | KIMBERLY-CLARK PROFESSIONAL JACKET |
| Classification | Gown, Examination |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Cynthia E Smith |
| Correspondent | Cynthia E Smith KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | FME |
| CFR Regulation Number | 880.6265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-28 |
| Decision Date | 1988-02-19 |