VNACE FASCIAL DILATOR SET
FDA 510(k) clearance K811833 · decided 1981-07-10
Clearance details
- K-number
- K811833
- Device name
- VNACE FASCIAL DILATOR SET
- Applicant
- Vance Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-30
- Decision date
- 1981-07-10
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- KOE
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Irel recall (Z-1584-05) | Cook Urological, Inc. | 2005-09-24 |