Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K982289 |
Device Name |
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 06/30/1998 |
Decision Date | 08/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|