Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K993749 |
Device Name |
GYRUS HYSTEROSCOPIC RESECTOSCOPE |
Applicant |
GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS |
CARDIFF,
GB
CF3 0LT
|
|
Applicant Contact |
DAVID KAY |
Correspondent |
GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS |
CARDIFF,
GB
CF3 0LT
|
|
Correspondent Contact |
DAVID KAY |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 11/05/1999 |
Decision Date | 12/03/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|