FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
LOFRIC(R), LOFRIC(R) CATH-KIT
K Number: K896750
·
Decision Aug 6, 1990
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
3
Review Days
249
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Basic Information
- Device Name
- LOFRIC(R), LOFRIC(R) CATH-KIT
- K Number
- K896750
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Astra Meditec AB
- Date Received
- November 30, 1989
- Decision Date
- August 6, 1990
- 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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