The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for White Knight Disp. Sterile Back Gown.
| Device ID | K800927 |
| 510k Number | K800927 |
| Device Name: | WHITE KNIGHT DISP. STERILE BACK GOWN |
| Classification | Gown, Surgical |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-20 |