FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALLERGY CONTROL COVERS
K Number: K903382
·
Decision Nov 2, 1990
Classifications
1
FEI Numbers
210
Registration Numbers
210
Same Product Code
13
Applicant Total
1
Review Days
98
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Basic Information
- Device Name
- ALLERGY CONTROL COVERS
- K Number
- K903382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6190
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Allergy Control Products, Inc.
- Date Received
- July 27, 1990
- Decision Date
- November 2, 1990
- 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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