The following data is part of a premarket notification filed by Levtrade Intl. (pty) Ltd. with the FDA for Burnshield Trauma Dressing.
| Device ID | K921471 |
| 510k Number | K921471 |
| Device Name: | BURNSHIELD TRAUMA DRESSING |
| Classification | Sheet, Burn |
| Applicant | LEVTRADE INTL. (PTY) LTD. PERSEUS PARK, PRIORY ROAD, LYNNWOOD RIDGE Petoria, South Africa, ZA |
| Contact | A. M Vibnings |
| Correspondent | A. M Vibnings LEVTRADE INTL. (PTY) LTD. PERSEUS PARK, PRIORY ROAD, LYNNWOOD RIDGE Petoria, South Africa, ZA |
| Product Code | FPY |
| CFR Regulation Number | 880.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1993-04-20 |