COE-SIL
FDA 510(k) clearance K792428 · decided 1980-01-23
Clearance details
- K-number
- K792428
- Device name
- COE-SIL
- Applicant
- Coe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-27
- Decision date
- 1980-01-23
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- LDG
- Device class
- 1
- Regulation number
- 874.3300
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coe Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PHYSICIANS CHOICE SILICONE EAR PUTTY (K823921) | Santa Barbara Medco, Inc. | 1983-03-28 |
Recalls involving this device
No recalls on record reference this clearance.