FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBE-BANDAGE FOR HUMAN DIGITS 200
K Number: K840107
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
1
Review Days
106
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Basic Information
- Device Name
- TUBE-BANDAGE FOR HUMAN DIGITS 200
- K Number
- K840107
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Zens Health Care Products
- Date Received
- January 10, 1984
- Decision Date
- April 25, 1984
- Product Code
- FQM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQM | Bandage, Elastic | FDA class 1 | General Hospital |
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