AUDI-SIL EARMOLD MATERIAL
FDA 510(k) clearance K771615 · decided 1977-08-30
Clearance details
- K-number
- K771615
- Device name
- AUDI-SIL EARMOLD MATERIAL
- Applicant
- Coe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-24
- Decision date
- 1977-08-30
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- ESH
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.