TRACHEOSTOMY CLEANSING SOLUTION
FDA 510(k) clearance K862563 · decided 1986-07-15
Clearance details
- K-number
- K862563
- Device name
- TRACHEOSTOMY CLEANSING SOLUTION
- Applicant
- Clinipad Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-03
- Decision date
- 1986-07-15
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- EPE
- Device class
- 1
- Regulation number
- 868.5795
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Guilford, CT, 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 |
|---|---|---|
| UPDATED STERILE ENDOTRACHEAL BRUSHES (K863635) | Biological & Environmental Control Laboratories | 1986-11-03 |
Recalls involving this device
No recalls on record reference this clearance.