HALUX EXLITE MINOR SURGERY LIGHT
FDA 510(k) clearance K896961 · decided 1990-02-22
Clearance details
- K-number
- K896961
- Device name
- HALUX EXLITE MINOR SURGERY LIGHT
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-15
- Decision date
- 1990-02-22
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- GBC
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, 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 |
|---|---|---|
| FLAT SUCTION DRAIN (K830610) | Sil-Med Corp. | 1983-03-29 |
| SKYTRON ELITE SURGICAL TABLES (K811311) | Skytron, Div. the Kmw Group, Inc. | 1981-06-02 |
| MINOR SURGERY LIGHT (K810207) | Cavitron Corp. | 1981-02-13 |
Recalls involving this device
No recalls on record reference this clearance.