DELTA-ROL
FDA 510(k) clearance K790340 · decided 1979-04-12
Clearance details
- K-number
- K790340
- Device name
- DELTA-ROL
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-21
- Decision date
- 1979-04-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GCO
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Raynham, MA, 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 |
|---|---|---|
| CYTOTECH HSV IGG ENZYME IMMUNOASSAY (K862838) | Cytotech, Inc. | 1986-12-09 |
| HAND MIRROR (ENDOSCOPE) (K862717) | Simpson/Basye, Inc. | 1986-07-30 |
Recalls involving this device
No recalls on record reference this clearance.