FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
K Number: K041833
·
Decision Dec 10, 2004
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
179
Applicant Total
1
Review Days
156
Basic Information
- Device Name
- CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
- K Number
- K041833
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CONSOLIDATED MACHINE CORP.
- Date Received
- July 7, 2004
- Decision Date
- December 10, 2004
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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