FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ENTROKIT WITH MAGLINTE CATHETER
K Number: K860441
·
Decision Mar 12, 1986
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
4
Review Days
36
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Basic Information
- Device Name
- ENTROKIT WITH MAGLINTE CATHETER
- K Number
- K860441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Lafayette Pharmacal, Inc.
- Date Received
- February 4, 1986
- Decision Date
- March 12, 1986
- Product Code
- KGC
- 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 |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | FDA class 2 | Gastroenterology, Urology |
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