STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
FDA 510(k) clearance K875280 · decided 1988-09-13
Clearance details
- K-number
- K875280
- Device name
- STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
- Applicant
- Steris C/O Medical Device Consultants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-24
- Decision date
- 1988-09-13
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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