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 |