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 |