FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLAMP, INCONTINENCE, BAUMRUCKER
K Number: K780137
·
Decision Apr 28, 1978
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
10
Applicant Total
4
Review Days
93
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Basic Information
- Device Name
- CLAMP, INCONTINENCE, BAUMRUCKER
- K Number
- K780137
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5160
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Greenwald Surgical Co., Inc.
- Date Received
- January 25, 1978
- Decision Date
- April 28, 1978
- Product Code
- FHA
- 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 |
|---|---|---|---|
| FHA | Clamp, Penile | FDA class 1 | Gastroenterology, Urology |
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