510(k) K832590
- Device
- MOUTH-TO-MOUTH SHIELD APPLICATOR
- Applicant
- MEM, INC.
- 510(k) number
- K832590
- Product code
- LAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-08-02
- Regulation
- 862.3270
- Classification name
- High Pressure Liquid Chromatography, Codeine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851480 | VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW | Vygon Corp. | 1985-05-07 |
Legacy Summary#
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FDA Review#
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