FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLO-TAPE
K Number: K791146
·
Decision Jul 30, 1979
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
5
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- COLO-TAPE
- K Number
- K791146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Suburban Ostomy Supply Co., Inc.
- Date Received
- June 18, 1979
- Decision Date
- July 30, 1979
- Product Code
- EZR
- 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 |
|---|---|---|---|
| EZR | Cement, Stomal Appliance, Ostomy | FDA class 1 | Gastroenterology, Urology |
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