510(k) K851480
- Device
- VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW
- Applicant
- VYGON CORP.
- 510(k) number
- K851480
- Product code
- LAE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-07
- Date received
- 1985-04-15
- 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#
- Contact
- TONY J RIVERS
- Address
- 1 Madison St. East Rutherford NJ US 07073 07073
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832590 | MOUTH-TO-MOUTH SHIELD APPLICATOR | Mem, Inc. | 1983-10-14 |
Legacy Summary#
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FDA Review#
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