The following data is part of a premarket notification filed by Levtrade Intl. (pty) Ltd. with the FDA for Burnfree Burnsoothe Hydrogel.
| Device ID | K943728 |
| 510k Number | K943728 |
| Device Name: | BURNFREE BURNSOOTHE HYDROGEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | LEVTRADE INTL. (PTY) LTD. 22 CENTRAL ST. P.O. BOX 150 Kingham, MA 02043 |
| Contact | William M Koplovsky |
| Correspondent | William M Koplovsky LEVTRADE INTL. (PTY) LTD. 22 CENTRAL ST. P.O. BOX 150 Kingham, MA 02043 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06007645007917 | K943728 | 000 |
| 16007645007648 | K943728 | 000 |
| 36007645005303 | K943728 | 000 |
| 26007645004590 | K943728 | 000 |
| 36007645001541 | K943728 | 000 |
| 06007645000161 | K943728 | 000 |
| 16007645001431 | K943728 | 000 |
| 16007645004302 | K943728 | 000 |
| 16007645006344 | K943728 | 000 |
| 16007645006337 | K943728 | 000 |
| 16007645005804 | K943728 | 000 |
| 16007645001424 | K943728 | 000 |
| 16007645000120 | K943728 | 000 |
| 16007645007921 | K943728 | 000 |
| 16007645002001 | K943728 | 000 |
| 10830868000037 | K943728 | 000 |
| 16007645007655 | K943728 | 000 |
| 06007645000222 | K943728 | 000 |
| 36007645000193 | K943728 | 000 |
| 16007645007679 | K943728 | 000 |
| 16007645007662 | K943728 | 000 |
| 26007645006358 | K943728 | 000 |
| 16007645006054 | K943728 | 000 |
| 16007645006047 | K943728 | 000 |
| 16007645003954 | K943728 | 000 |
| 06007645003537 | K943728 | 000 |
| 16007645003527 | K943728 | 000 |
| 06007645002073 | K943728 | 000 |
| 26007645001452 | K943728 | 000 |
| 26007645001414 | K943728 | 000 |
| 16007645001400 | K943728 | 000 |
| 06007645001397 | K943728 | 000 |
| 96007645001383 | K943728 | 000 |
| 16007645000212 | K943728 | 000 |
| 16007645005781 | K943728 | 000 |