FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
K Number: K863830
·
Decision Oct 16, 1986
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
5
Applicant Total
71
Review Days
16
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Basic Information
- Device Name
- CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
- K Number
- K863830
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Coloplast A/S
- Date Received
- September 30, 1986
- Decision Date
- October 16, 1986
- Product Code
- EZQ
- 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 |
|---|---|---|---|
| EZQ | Pouch, Colostomy | FDA class 1 | Gastroenterology, Urology |
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