FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K Number: K891986
·
Decision Dec 29, 1989
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
5
Review Days
276
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Basic Information
- Device Name
- MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
- K Number
- K891986
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mark One Healthcare Products
- Date Received
- March 28, 1989
- Decision Date
- December 29, 1989
- Product Code
- KME
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
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