The following data is part of a premarket notification filed by Sri/surgical Express, Inc. with the FDA for Sri/surgical Express Sp Reusable Surgical Gown.
| Device ID | K023635 |
| 510k Number | K023635 |
| Device Name: | SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | SRI/SURGICAL EXPRESS, INC. 12425 RACE TRACK RD. Tampa, FL 33626 |
| Contact | Jack A Hamilton |
| Correspondent | Jack A Hamilton SRI/SURGICAL EXPRESS, INC. 12425 RACE TRACK RD. Tampa, FL 33626 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-29 |
| Decision Date | 2002-11-18 |
| Summary: | summary |