The following data is part of a premarket notification filed by Sri Surgical with the FDA for Sri Level Ii Surgical Gown.
| Device ID | K090383 |
| 510k Number | K090383 |
| Device Name: | SRI LEVEL II SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | SRI SURGICAL 12425 RACE TRACK RD. Tampa, FL 33626 |
| Contact | Nissa Mulnick |
| Correspondent | Nissa Mulnick SRI SURGICAL 12425 RACE TRACK RD. Tampa, FL 33626 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-17 |
| Decision Date | 2009-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812564039583 | K090383 | 000 |
| 00812564031532 | K090383 | 000 |
| 00812564031266 | K090383 | 000 |
| 00812564031167 | K090383 | 000 |
| 00812564031099 | K090383 | 000 |
| 00812564031013 | K090383 | 000 |
| 00812564031006 | K090383 | 000 |
| 00812564030481 | K090383 | 000 |
| 00812564030436 | K090383 | 000 |
| 00812564030429 | K090383 | 000 |
| 00812564030412 | K090383 | 000 |
| 00812564030405 | K090383 | 000 |
| 00812564030351 | K090383 | 000 |
| 00812564030290 | K090383 | 000 |
| 00810019800832 | K090383 | 000 |
| 00812564032164 | K090383 | 000 |
| 00812564032201 | K090383 | 000 |
| 00812564033185 | K090383 | 000 |
| 00812564039507 | K090383 | 000 |
| 00812564039347 | K090383 | 000 |
| 00812564038975 | K090383 | 000 |
| 00812564038692 | K090383 | 000 |
| 00812564038326 | K090383 | 000 |
| 00812564038234 | K090383 | 000 |
| 00812564036155 | K090383 | 000 |
| 00812564036148 | K090383 | 000 |
| 00812564035356 | K090383 | 000 |
| 00812564035264 | K090383 | 000 |
| 00812564035257 | K090383 | 000 |
| 00812564035240 | K090383 | 000 |
| 00812564035073 | K090383 | 000 |
| 00812564033703 | K090383 | 000 |
| 00810019800825 | K090383 | 000 |