The following data is part of a premarket notification filed by Sri/surgical Express, Inc. with the FDA for Sri Lp Gown.
| Device ID | K080723 |
| 510k Number | K080723 |
| Device Name: | SRI LP GOWN |
| Classification | Gown, Surgical |
| Applicant | SRI/SURGICAL EXPRESS, INC. P.O. BOX 92493 Austin, TX 78709 |
| Contact | Jeffery O Stull |
| Correspondent | Jeffery O Stull SRI/SURGICAL EXPRESS, INC. 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564034304 | K080723 | 000 |
| 00812564031785 | K080723 | 000 |
| 00812564031587 | K080723 | 000 |
| 00812564031549 | K080723 | 000 |
| 00812564031525 | K080723 | 000 |
| 00812564031518 | K080723 | 000 |
| 00812564031501 | K080723 | 000 |