Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K093079 |
Device Name |
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U |
Applicant |
HOBBS MEDICAL, INC. |
8 SPRING ST. |
STAFFORD SPRINGS,
CT
06076
|
|
Applicant Contact |
EMILY MADSEN |
Correspondent |
HOBBS MEDICAL, INC. |
8 SPRING ST. |
STAFFORD SPRINGS,
CT
06076
|
|
Correspondent Contact |
EMILY MADSEN |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 09/30/2009 |
Decision Date | 08/02/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|