FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
K Number: K852956
·
Decision Aug 9, 1985
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
68
Applicant Total
30
Review Days
29
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Basic Information
- Device Name
- CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
- K Number
- K852956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1275
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Parker Laboratories, Inc.
- Date Received
- July 11, 1985
- Decision Date
- August 9, 1985
- 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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| K864556 | AQUALUBE(TM) | Dec 1, 1986 | Substantially Equivalent |
| K861239 | ACRYLIC SOLDER | Apr 17, 1986 | Substantially Equivalent |
| K855167 | DYNA SYSTEM | Mar 4, 1986 | Substantially Equivalent |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent |
| K841400 | NEURO PULSE | Jun 15, 1984 | Substantially Equivalent |
| K840548 | RESIL | Apr 17, 1984 | Substantially Equivalent |
| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 | Substantially Equivalent |