FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLORADO NEEDLE ELECTRODE
K Number: K881763
·
Decision Jun 20, 1988
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
1
Review Days
56
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Basic Information
- Device Name
- COLORADO NEEDLE ELECTRODE
- K Number
- K881763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Colorado Biomedical, Inc.
- Date Received
- April 25, 1988
- Decision Date
- June 20, 1988
- Product Code
- JOS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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