HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
FDA 510(k) clearance K943654 · decided 1995-08-02
Clearance details
- K-number
- K943654
- Device name
- HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
- Applicant
- Mdt Biologic Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-28
- Decision date
- 1995-08-02
- Days to decision
- 370 days
- Clearance type
- Traditional
- Product code
- MLR
- Device class
- 2
- Regulation number
- 880.6860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rancho Dominguez, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.