FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUMEVAC
K Number: K874410
·
Decision Dec 3, 1987
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
1
Applicant Total
1
Review Days
36
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Basic Information
- Device Name
- CUMEVAC
- K Number
- K874410
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4370
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cumes-Honikman Partnership
- Date Received
- October 28, 1987
- Decision Date
- December 3, 1987
- Product Code
- FFD
- 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 |
|---|---|---|---|
| FFD | Evacuator, Bladder, Manually Operated | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
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