REGNELL HYDRAULIC FEMORAL PROTHESIS
FDA 510(k) clearance K830285 · decided 1983-03-09
Clearance details
- K-number
- K830285
- Device name
- REGNELL HYDRAULIC FEMORAL PROTHESIS
- Applicant
- Besco Financial Service
- Decision
- Substantially Equivalent
- Date received
- 1983-01-27
- Decision date
- 1983-03-09
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- KFX
- Device class
- 2
- Regulation number
- 890.3500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| STERILE LEMAITRE GLOW 'N TELL TAPE (K932184) | Vascutech, Inc. | 1993-07-22 |
| IPOS G.L.P. SYSTEM (K833868) | Ipos Luneburg | 1983-11-28 |
| ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (K822240) | American Mcgaw | 1982-12-30 |
Recalls involving this device
No recalls on record reference this clearance.