The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for First Aid/truma Kit.
| Device ID | K941311 |
| 510k Number | K941311 |
| Device Name: | FIRST AID/TRUMA KIT |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766588069944 | K941311 | 000 |
| 00766588030319 | K941311 | 000 |
| 00766588030302 | K941311 | 000 |
| 00766588029252 | K941311 | 000 |