FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K Number: K012374
·
Decision Aug 23, 2001
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
28
Review Days
28
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Basic Information
- Device Name
- MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
- K Number
- K012374
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astra Tech, Inc.
- Date Received
- July 26, 2001
- Decision Date
- August 23, 2001
- Product Code
- GBM
- 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 |
|---|---|---|---|
| GBM | Catheter, Urethral | FDA class 2 | Gastroenterology, Urology |
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