CASTLE WASHER/DISINFECTOR, MODEL 7550
FDA 510(k) clearance K911087 · decided 1993-08-09
Clearance details
- K-number
- K911087
- Device name
- CASTLE WASHER/DISINFECTOR, MODEL 7550
- Applicant
- Mdt Biologic Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1993-08-09
- Days to decision
- 882 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.