STEAMPLUS STEAM INTEGRATOR
FDA 510(k) clearance K063799 · decided 2007-01-05
Clearance details
- K-number
- K063799
- Device name
- STEAMPLUS STEAM INTEGRATOR
- Applicant
- Spsmedical Supply Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-22
- Decision date
- 2007-01-05
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rush, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.