FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRAPH FLASH, MODEL CI 110
K Number: K012732
·
Decision Mar 4, 2002
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
12
Review Days
200
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Basic Information
- Device Name
- INTEGRAPH FLASH, MODEL CI 110
- K Number
- K012732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Steritec Products, Inc.
- Date Received
- August 16, 2001
- Decision Date
- March 4, 2002
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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| K003533 | CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L | Feb 7, 2001 | Substantially Equivalent |
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| K002861 | EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 | Nov 29, 2000 | Substantially Equivalent |
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