FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
K Number: K925102
·
Decision Jun 9, 1994
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
857
Review Days
609
Basic Information
- Device Name
- FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
- K Number
- K925102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- ABBOTT LABORATORIES
- Date Received
- October 8, 1992
- Decision Date
- June 9, 1994
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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