FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
K Number: K850287
·
Decision Mar 7, 1985
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
55
Applicant Total
61
Review Days
42
Basic Information
- Device Name
- MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
- K Number
- K850287
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- MENTOR CORP.
- Date Received
- January 24, 1985
- Decision Date
- March 7, 1985
- Product Code
- LJE
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
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