Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K963338 |
Device Name |
UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH |
Applicant |
UNIMED SURGICAL PRODUCTS, INC. |
10401 BELCHER RD. |
LARGO,
FL
33777
|
|
Applicant Contact |
RONALD R FROEMMING |
Correspondent |
UNIMED SURGICAL PRODUCTS, INC. |
10401 BELCHER RD. |
LARGO,
FL
33777
|
|
Correspondent Contact |
RONALD R FROEMMING |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/23/1996 |
Decision Date | 10/21/1996 |
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
|