Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K081070 |
FOIA Releasable 510(k) |
K081070
|
Device Name |
INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM |
Applicant |
INTERLACE MEDICAL, INC. |
139 NEWBURY STREET |
FRAMINGHAM,
MA
01701
|
|
Applicant Contact |
RON ADAMS |
Correspondent |
INTERLACE MEDICAL, INC. |
139 NEWBURY STREET |
FRAMINGHAM,
MA
01701
|
|
Correspondent Contact |
RON ADAMS |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 04/15/2008 |
Decision Date | 07/23/2008 |
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
|
|
|