FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE TUCKER-SACH FOOT AND TUCKER-SYME FT
K Number: K791331
·
Decision Aug 3, 1979
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
3
Applicant Total
1
Review Days
16
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Basic Information
- Device Name
- THE TUCKER-SACH FOOT AND TUCKER-SYME FT
- K Number
- K791331
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Kiswood Manufacturing, Inc.
- Date Received
- July 18, 1979
- Decision Date
- August 3, 1979
- Product Code
- ISH
- 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 |
|---|---|---|---|
| ISH | Component, External, Limb, Ankle/Foot | FDA class 1 | Physical Medicine |
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