MOUTH-TO-MOUTH SHIELD APPLICATOR
FDA 510(k) clearance K832590 · decided 1983-10-14
Clearance details
- K-number
- K832590
- Device name
- MOUTH-TO-MOUTH SHIELD APPLICATOR
- Applicant
- Mem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-02
- Decision date
- 1983-10-14
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LAE
- Device class
- 2
- Regulation number
- 862.3270
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW (K851480) | Vygon Corp. | 1985-05-07 |
Recalls involving this device
No recalls on record reference this clearance.