RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
FDA 510(k) clearance K982130 · decided 1998-08-07
Clearance details
- K-number
- K982130
- Device name
- RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
- Applicant
- New Deantronics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-17
- Decision date
- 1998-08-07
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. recall (Z-1142-2010) | ConvaTec | 2010-03-16 |