The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Certiburn Burn/trauma Face Dressing, Towel Dressing.
| Device ID | K946338 |
| 510k Number | K946338 |
| Device Name: | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Gerson |
| Correspondent | Howard Gerson CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-29 |
| Decision Date | 1995-03-29 |