The following data is part of a premarket notification filed by Sri/surgical Express with the FDA for Sri Plr Gown.
| Device ID | K080707 |
| 510k Number | K080707 |
| Device Name: | SRI PLR GOWN |
| Classification | Gown, Surgical |
| Applicant | SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin, TX 78709 |
| Contact | Jeffrey O Stull |
| Correspondent | Jeffrey O Stull SRI/SURGICAL EXPRESS P.O. BOX 92493 Austin, TX 78709 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-12 |
| Decision Date | 2008-11-13 |