FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY DRAINAGE BAG
K Number: K781987
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
2
Review Days
10
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Basic Information
- Device Name
- URINARY DRAINAGE BAG
- K Number
- K781987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Kelsar Corp.
- Date Received
- November 24, 1978
- Decision Date
- December 4, 1978
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Kelsar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K790005 | ADMINISTRATION SET, ENEMA | Jan 17, 1979 | Substantially Equivalent |