FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARLEN ULTRA ILEOSTOMY POUCH-5000
K Number: K880327
·
Decision Feb 19, 1988
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
5
Applicant Total
1
Review Days
24
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Basic Information
- Device Name
- MARLEN ULTRA ILEOSTOMY POUCH-5000
- K Number
- K880327
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Marlen Mfg. & Development Co.
- Date Received
- January 26, 1988
- Decision Date
- February 19, 1988
- 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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