FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5
K Number: K770969
·
Decision Jun 24, 1977
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
32
Review Days
24
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Basic Information
- Device Name
- CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5
- K Number
- K770969
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cavitron Corp.
- Date Received
- May 31, 1977
- Decision Date
- June 24, 1977
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent |
| K782054 | LASER, CO2 SURGICAL | Jan 17, 1979 | Substantially Equivalent |