FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WRIGHT CARE
K Number: K823497
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
74
Review Days
45
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Basic Information
- Device Name
- WRIGHT CARE
- K Number
- K823497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Wright
- Date Received
- November 23, 1982
- Decision Date
- January 7, 1983
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 2, 1993 | Substantially Equivalent |