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 | K940249 |
510k Number | K940249 |
Device Name: | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING |
Classification | First Aid Kit With Drug |
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 | LRR |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-19 |
Decision Date | 1994-10-03 |