FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHUR-PATCH TAPE PATCH
K Number: K803012
·
Decision Dec 30, 1980
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
3
Review Days
32
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Basic Information
- Device Name
- SHUR-PATCH TAPE PATCH
- K Number
- K803012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Shur Medical Corp.
- Date Received
- November 28, 1980
- Decision Date
- December 30, 1980
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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