FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOF-BAND HIGH STRETCH BANDAGES
K Number: K810137
·
Decision Feb 17, 1981
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
206
Review Days
27
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Basic Information
- Device Name
- SOF-BAND HIGH STRETCH BANDAGES
- K Number
- K810137
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- January 21, 1981
- Decision Date
- February 17, 1981
- 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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