The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Impervious Open Back Gown.
| Device ID | K880382 |
| 510k Number | K880382 |
| Device Name: | KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN |
| Classification | Gown, Surgical |
| 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-28 |
| Decision Date | 1988-06-23 |