The following data is part of a premarket notification filed by Levtrade Intl. (pty) Ltd. with the FDA for Burnfree Burnsoothe Hydrogel Burn Blotts.
| Device ID | K943470 |
| 510k Number | K943470 |
| Device Name: | BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS |
| 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 |