FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COUGH PILLOW
K Number: K893809
·
Decision Aug 28, 1989
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
4
Applicant Total
1
Review Days
98
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Basic Information
- Device Name
- COUGH PILLOW
- K Number
- K893809
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5160
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Custom Hospitals Products
- Date Received
- May 22, 1989
- Decision Date
- August 28, 1989
- Product Code
- KMO
- 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 |
|---|---|---|---|
| KMO | Binder, Elastic | FDA class 1 | General Hospital |
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