Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
- Page Type
- Product Code
- Definition
- THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
- Regulation Medical Specialty
- General Hospital
- Review Panel
- Ear, Nose, Throat
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 880.5045
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 880.5045 Medical recirculating air cleaner
§ 880.5045 Medical recirculating air cleaner.
(a) Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.
(b) Classification. Class II (performance standards).