FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K Number: K982970
·
Decision Oct 28, 1998
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
3
Review Days
64
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Basic Information
- Device Name
- MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
- K Number
- K982970
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Manufacturing and Research, Inc.
- Date Received
- August 25, 1998
- Decision Date
- October 28, 1998
- Product Code
- EZL
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
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