FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON
K Number: K925466
·
Decision Aug 26, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
6
Review Days
301
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Basic Information
- Device Name
- CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON
- K Number
- K925466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Uni-Patch, Inc.
- Date Received
- October 29, 1992
- Decision Date
- August 26, 1993
- 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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|---|---|---|---|
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| K871222 | TANTONE MULTI-DAY #633 TENS ELECTRODE | May 29, 1987 | Substantially Equivalent |