FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNACOR STERILE CLOSED SYS. DRAINAGE BAG
K Number: K791969
·
Decision Nov 5, 1979
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
238
Review Days
34
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Basic Information
- Device Name
- DYNACOR STERILE CLOSED SYS. DRAINAGE BAG
- K Number
- K791969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medline Industries, Inc.
- Date Received
- October 2, 1979
- Decision Date
- November 5, 1979
- 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 |
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