FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECA GEL
K Number: K792488
·
Decision Feb 5, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
10
Review Days
64
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Basic Information
- Device Name
- ECA GEL
- K Number
- K792488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Vanaray Laboratories, Inc.
- Date Received
- December 3, 1979
- Decision Date
- February 5, 1980
- Product Code
- GYB
- 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 |
|---|---|---|---|
| GYB | Media, Electroconductive | FDA class 2 | Neurology |
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Other Clearances by Vanaray Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802647 | ECA GEL PROUDUCT REFORMULATION | Jan 8, 1981 | Substantially Equivalent |
| K802648 | UCA CREAM PRODUCT REFORMULATION | Nov 26, 1980 | Substantially Equivalent |
| K802649 | UCA GEL PRODUCT REFORMAULATION | Nov 12, 1980 | Substantially Equivalent |
| K802650 | UCA LOTION PRODUCT REFORMULATION | Nov 12, 1980 | Substantially Equivalent |
| K801383 | ECA CREAM REFORMULATION | Jun 17, 1980 | Substantially Equivalent |
| K792490 | UCA LOTION | Feb 22, 1980 | Substantially Equivalent |
| K792489 | UCA CREAM | Feb 5, 1980 | Substantially Equivalent |
| K792491 | ECA CREAM | Feb 5, 1980 | Substantially Equivalent |
| K792492 | UCA GEL | Feb 5, 1980 | Substantially Equivalent |