FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INCONTINENT PAD & BELT
K Number: K810544
·
Decision Mar 11, 1981
Classifications
1
FEI Numbers
417
Registration Numbers
418
Same Product Code
55
Applicant Total
3
Review Days
12
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Basic Information
- Device Name
- INCONTINENT PAD & BELT
- K Number
- K810544
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5920
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Principle Business Ent.
- Date Received
- February 27, 1981
- Decision Date
- March 11, 1981
- Product Code
- EYQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | FDA class 1 | Gastroenterology, Urology |
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