PHYSICIANS CHOICE SILICONE EAR PUTTY
FDA 510(k) clearance K823921 · decided 1983-03-28
Clearance details
- K-number
- K823921
- Device name
- PHYSICIANS CHOICE SILICONE EAR PUTTY
- Applicant
- Santa Barbara Medco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-28
- Decision date
- 1983-03-28
- Days to decision
- 90 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
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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 |
|---|---|---|
| COE-SIL (K792428) | Coe Laboratories, Inc. | 1980-01-23 |
Recalls involving this device
No recalls on record reference this clearance.