Device Classification Name |
Colposcope (And Colpomicroscope)
|
510(k) Number |
K963593 |
Device Name |
IMT LOUPE-COLPOSCOPE |
Applicant |
INVENTIVE MEDICAL TECHNOLOGY |
4361 BAILDON RD. |
TRAPPE,
MD
21673 -1807
|
|
Applicant Contact |
THEODORE P REED |
Correspondent |
INVENTIVE MEDICAL TECHNOLOGY |
4361 BAILDON RD. |
TRAPPE,
MD
21673 -1807
|
|
Correspondent Contact |
THEODORE P REED |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 09/09/1996 |
Decision Date | 04/22/1997 |
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
|
|
|