FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
K Number: K992702
·
Decision Nov 8, 1999
Classifications
1
FEI Numbers
210
Registration Numbers
210
Same Product Code
13
Applicant Total
1
Review Days
88
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Basic Information
- Device Name
- EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- K Number
- K992702
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6190
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergy Direct
- Date Received
- August 12, 1999
- Decision Date
- November 8, 1999
- Product Code
- FMW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | FDA class 1 | General Hospital |
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