Product Code: LFE
FDA class 2
21 CFR 880.6885
Solution, Cold Sterilizing
General Hospital
A cold sterilizing solution is a liquid chemical agent used to achieve high-level disinfection or sterilization of heat-sensitive medical instruments and devices that cannot withstand steam or dry-heat sterilization methods. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. It bears product code LFE and is regulated under 21 CFR 880.6885 within the General Hospital specialty. This device is eligible for third-party review.
510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
—
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Basic Information
- Product Code
- LFE
- Device Class
- FDA class 2
- Regulation Number
- 880.6885
- Medical Specialty
- General Hospital
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830106 | UNICIDE | Mar 07, 1983 | Substantially Equivalent | North Pacific Dental, Inc. |