PROTECTIVSTABILIZER
FDA 510(k) clearance K790186 · decided 1979-02-26
Clearance details
- K-number
- K790186
- Device name
- PROTECTIVSTABILIZER
- Applicant
- Jelco Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1979-01-29
- Decision date
- 1979-02-26
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GBJ
- Device class
- 1
- Regulation number
- 878.3750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| DUET (K934970) | Trulife , Ltd. | 1993-12-10 |
| OPERATING TABLE ACCESSORY CLAMP (K810282) | Minnesota Scientific, Inc. | 1981-02-26 |
| GORDON IVS INTRAVENOUS STABILIZER (K790946) | Whitman Medical Corp. | 1979-06-05 |
Recalls involving this device
No recalls on record reference this clearance.