The following data is part of a premarket notification filed by Mem, Inc. with the FDA for Mouth-to-mouth Shield Applicator.
| Device ID | K832590 |
| 510k Number | K832590 |
| Device Name: | MOUTH-TO-MOUTH SHIELD APPLICATOR |
| Classification | High Pressure Liquid Chromatography, Codeine |
| Applicant | MEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LAE |
| CFR Regulation Number | 862.3270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-10-14 |