JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
FDA 510(k) clearance K800623 · decided 1980-04-24
Clearance details
- K-number
- K800623
- Device name
- JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
- Applicant
- Pilling Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-19
- Decision date
- 1980-04-24
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KCD
- Device class
- 1
- Regulation number
- 874.4420
- 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 Pilling Co.
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 |
|---|---|---|
| VOLUMATIC (K844169) | Glaxo, Inc. | 1984-11-09 |
| ESOPHAGEAL BOUGIES (K822258) | Kelleher Corp. | 1982-08-25 |
Recalls involving this device
No recalls on record reference this clearance.