FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOFRIC SINGLE USE URINARY CATHETER
K Number: K113424
·
Decision Apr 17, 2012
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
72
Applicant Total
10
Review Days
148
Basic Information
- Device Name
- LOFRIC SINGLE USE URINARY CATHETER
- K Number
- K113424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASTRA TECH AB
- Date Received
- November 21, 2011
- Decision Date
- April 17, 2012
- Product Code
- EZD
- 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 |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
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| K091239 | ASTRA TECH IMPLANT SYSTEM | Sep 22, 2009 | Substantially Equivalent |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | Sep 17, 2008 | Substantially Equivalent |
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