FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FILLING VOLUME OPTION
K Number: K882295
·
Decision Sep 13, 1988
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
27
Applicant Total
3
Review Days
103
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Basic Information
- Device Name
- FILLING VOLUME OPTION
- K Number
- K882295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Eris Medical Technology
- Date Received
- June 2, 1988
- Decision Date
- September 13, 1988
- Product Code
- LJH
- 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 |
|---|---|---|---|
| LJH | System, Irrigation, Urological | FDA class 2 | Gastroenterology, Urology |
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