FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRAY, BLADDER IRRIGATION
K Number: K760047
·
Decision Mar 1, 1977
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
14
Applicant Total
4
Review Days
259
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Basic Information
- Device Name
- TRAY, BLADDER IRRIGATION
- K Number
- K760047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- M-C Ind., Inc.
- Date Received
- June 15, 1976
- Decision Date
- March 1, 1977
- Product Code
- EYN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| EYN | Tray, Irrigation, Sterile | FDA class 2 | Gastroenterology, Urology |
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