FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DEVICE FOR THE TREATMENT OF HEMORRHOIDS
K Number: K822649
·
Decision Nov 3, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
1
Review Days
63
Basic Information
- Device Name
- DEVICE FOR THE TREATMENT OF HEMORRHOIDS
- K Number
- K822649
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- DUNMORE CORP.
- Date Received
- September 1, 1982
- Decision Date
- November 3, 1982
- Product Code
- LKX
- 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 |
|---|---|---|---|
| LKX | Device, Thermal, Hemorrhoids | FDA unclassified | Unknown |
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