FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
K Number: K140589
·
Decision Dec 3, 2014
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
9
Review Days
271
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Basic Information
- Device Name
- STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR
- K Number
- K140589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mesa Laboratories, Inc.
- Date Received
- March 7, 2014
- Decision Date
- December 3, 2014
- Product Code
- FRC
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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