Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K092278 |
Device Name |
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 |
Applicant |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
GRAHAM A.L. BAILLIE |
Correspondent |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
GRAHAM A.L. BAILLIE |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 07/28/2009 |
Decision Date | 09/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|