Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K962935 |
Device Name |
UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE |
Applicant |
UNIMED SURGICAL PRODUCTS, INC. |
10401 BELCHER RD. |
LARGO,
FL
34647
|
|
Applicant Contact |
RONALD R FROEMMING |
Correspondent |
UNIMED SURGICAL PRODUCTS, INC. |
10401 BELCHER RD. |
LARGO,
FL
34647
|
|
Correspondent Contact |
RONALD R FROEMMING |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 07/29/1996 |
Decision Date | 09/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|