FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINE COLLECTION BAG TYPE 1505V
K Number: K802738
·
Decision Dec 18, 1980
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
205
Applicant Total
11
Review Days
45
Basic Information
- Device Name
- URINE COLLECTION BAG TYPE 1505V
- K Number
- K802738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- BIO D CORP.
- Date Received
- November 3, 1980
- Decision Date
- December 18, 1980
- Product Code
- KNX
- 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by BIO D CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K802729 | URINE COLLECTION BAG TYPE 2132V | Dec 18, 1980 | Substantially Equivalent |
| K802732 | URINE COLLECTION BAG TYPE AP2132V | Dec 18, 1980 | Substantially Equivalent |
| K802739 | URINE COLLECTION BAG TYPE 710AP | Dec 18, 1980 | Substantially Equivalent |
| K802736 | URINE COOLECTION BAG TYPE 2090V | Dec 18, 1980 | Substantially Equivalent |
| K802737 | URINE COLLECTION BAG TYPE 1590V | Dec 18, 1980 | Substantially Equivalent |
| K802735 | URINE COLLECTION BAG TYPE 740AP | Dec 18, 1980 | Substantially Equivalent |
| K802734 | URINE COLLECTION BAG TYPE 710 | Dec 18, 1980 | Substantially Equivalent |
| K802733 | URINE COLLECTION BAG TYPE AP2090V | Dec 18, 1980 | Substantially Equivalent |
| K802740 | FLUFF UNDERPAD TYPE UP1001 | Dec 10, 1980 | Substantially Equivalent |
| K802730 | FLUFF UNDERPAD TYPE UP1002 | Dec 10, 1980 | Substantially Equivalent |