WAVICIDE(R) -01
Device Facts
| Record ID | K914749 |
|---|---|
| Device Name | WAVICIDE(R) -01 |
| Applicant | Wave Energy Systems, Inc. |
| Product Code | MED · General Hospital |
| Decision Date | Aug 10, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6885 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
