LEKSELL STEREOACTIC SYSTEM
FDA 510(k) clearance K811726 · decided 1981-07-10
Clearance details
- K-number
- K811726
- Device name
- LEKSELL STEREOACTIC SYSTEM
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-18
- Decision date
- 1981-07-10
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LHF
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Downs Surgical
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 |
|---|---|---|
| 2M 9810 MICROWAVE OVEN (K811724) | Travenol Laboratories, S.A. | 1981-07-10 |
Recalls involving this device
No recalls on record reference this clearance.