FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lead-free Chemical Indicators for Steam Sterilization
K Number: K181788
·
Decision Mar 1, 2019
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
3
Review Days
239
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Basic Information
- Device Name
- Lead-free Chemical Indicators for Steam Sterilization
- K Number
- K181788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kem Medical Products Corp.
- Date Received
- July 5, 2018
- Decision Date
- March 1, 2019
- 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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