ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
FDA 510(k) clearance K822240 · decided 1982-12-30
Clearance details
- K-number
- K822240
- Device name
- ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
- Applicant
- American Mcgaw
- Decision
- Substantially Equivalent
- Date received
- 1982-07-27
- Decision date
- 1982-12-30
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- KFX
- Device class
- 2
- Regulation number
- 890.3500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Santa Ana, CA, 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 |
| REGNELL HYDRAULIC FEMORAL PROTHESIS (K830285) | Besco Financial Service | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.