FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERRAD 50/100S/200 TEST PACK
K Number: K130263
·
Decision Mar 28, 2014
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
202
Applicant Total
52
Review Days
417
Basic Information
- Device Name
- STERRAD 50/100S/200 TEST PACK
- K Number
- K130263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ADVANCED STERILIZATION PRODUCTS
- Date Received
- February 4, 2013
- Decision Date
- March 28, 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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| K Number | Device Name | ||
|---|---|---|---|
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