LFE · Solution, Cold Sterilizing
General Hospital · 21 CFR 880.6885 · Class 2
Overview
| Product Code | LFE |
|---|---|
| Device Name | Solution, Cold Sterilizing |
| Regulation | 21 CFR 880.6885 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.
Classification Rationale
Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
Special Controls
*Classification.* Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K830106 | UNICIDE | North Pacific Dental, Inc. | Mar 7, 1983 | SESE |
Top Applicants
- North Pacific Dental, Inc. — 1 clearance
