FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
K Number: K905573
·
Decision Jun 19, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
12
Applicant Total
3
Review Days
189
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Basic Information
- Device Name
- XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
- K Number
- K905573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Zeon Medical Corp.
- Date Received
- December 12, 1990
- Decision Date
- June 19, 1991
- Product Code
- BSS
- 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 |
|---|---|---|---|
| BSS | Tube, Nasogastric | FDA class 2 | Gastroenterology, Urology |
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