FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGLINTE ENTEROCLYSIS CATHETER
K Number: K884379
·
Decision Feb 28, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
4
Review Days
133
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Basic Information
- Device Name
- MAGLINTE ENTEROCLYSIS CATHETER
- K Number
- K884379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Lafayette Pharmacal, Inc.
- Date Received
- October 18, 1988
- Decision Date
- February 28, 1989
- Product Code
- FGD
- 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 |
|---|---|---|---|
| FGD | Catheter, Retention, Barium Enema With Bag | FDA class 2 | Gastroenterology, Urology |
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