VERIFY 275F GRAVITY INDICATORS
FDA 510(k) clearance K083643 · decided 2009-08-07
Clearance details
- K-number
- K083643
- Device name
- VERIFY 275F GRAVITY INDICATORS
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-12-09
- Decision date
- 2009-08-07
- Days to decision
- 241 days
- Clearance type
- Abbreviated
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- 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
No recalls on record reference this clearance.