HASSON BUEC-3
FDA 510(k) clearance K820672 · decided 1982-07-30
Clearance details
- K-number
- K820672
- Device name
- HASSON BUEC-3
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1982-03-11
- Decision date
- 1982-07-30
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- HDP
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|
| SINGLE CHANNEL BALLOON CANNULA (K974801) | Conkin Surgical Instruments , Ltd. | 1998-07-09 |
| COLPO CUP CVC-2000 (K974563) | Clinical Innovations, Inc. | 1998-03-02 |
| HYSTERO KIT (K882054) | Zinnanti Surgical Instruments, Inc. | 1988-09-29 |
Recalls involving this device
No recalls on record reference this clearance.