Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
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- Subpart D—Prosthetic DevicesCFR Sub-Part
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- Subpart F—Therapeutic DevicesCFR Sub-Part
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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Solution, Cold Sterilizing
- Page Type
- Product Code
- Regulation Medical Specialty
- General Hospital
- Review Panel
- Dental
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 880.6885
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 880.6885 Liquid chemical sterilants/high level disinfectants
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a) 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.
(b) 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.
[65 FR 36325, June 8, 2000]