VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k) clearance K062297 · decided 2007-10-04
Clearance details
- K-number
- K062297
- Device name
- VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-08-07
- Decision date
- 2007-10-04
- Days to decision
- 423 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Amsco V-PRO 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Ser recall (Z-3041-2011) | Steris Corporation | 2011-08-19 |