FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLOSED SYSTEM URETHRAL CATHETERIZ. SET
K Number: K803259
·
Decision Jan 9, 1981
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
49
Review Days
17
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Basic Information
- Device Name
- CLOSED SYSTEM URETHRAL CATHETERIZ. SET
- K Number
- K803259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Devices, Inc.
- Date Received
- December 23, 1980
- Decision Date
- January 9, 1981
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |