The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Boundary Single-use Or Gown.
| Device ID | K842958 |
| 510k Number | K842958 |
| Device Name: | BOUNDARY SINGLE-USE OR GOWN |
| Classification | Gown, Surgical |
| Applicant | PROCTER & GAMBLE MFG. 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 | 1984-07-27 |
| Decision Date | 1984-08-17 |