FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
K Number: K870149
·
Decision Apr 6, 1987
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
56
Review Days
83
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Basic Information
- Device Name
- MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
- K Number
- K870149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Radionics, Inc.
- Date Received
- January 13, 1987
- Decision Date
- April 6, 1987
- 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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| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Mar 20, 2000 | Substantially Equivalent |
| K993594 | CONFORMAX MMLC VR1 | Dec 15, 1999 | Substantially Equivalent |
| K991399 | RADIONICS MICROELECTRODE KIT | Sep 21, 1999 | Substantially Equivalent |