FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCC22/ SCC26 SHOWER COMMODE CHAIR
K Number: K943293
·
Decision Aug 19, 1994
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
23
Review Days
42
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Basic Information
- Device Name
- SCC22/ SCC26 SHOWER COMMODE CHAIR
- K Number
- K943293
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- O'Tec Corp.
- Date Received
- July 8, 1994
- Decision Date
- August 19, 1994
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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FDA 510(k)
FDA Class 1
·Physical Medicine
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|---|---|---|---|
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| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905358 | CANCELLOUS SCREW | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905355 | BROAD SELF-COMPRESSING PLATE | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | Dec 11, 1990 | Substantially Equivalent |
| K905344 | KNOWLES PIN | Dec 11, 1990 | Substantially Equivalent |
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