FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXION MITTENS
K Number: K771030
·
Decision Jun 27, 1977
Classifications
1
FEI Numbers
107
Registration Numbers
107
Same Product Code
10
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- FLEXION MITTENS
- K Number
- K771030
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5350
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Stat Medical Corp.
- Date Received
- June 9, 1977
- Decision Date
- June 27, 1977
- Product Code
- IOD
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOD | Components, Exercise | FDA class 1 | Physical Medicine |
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