Device Classification Name |
colposcope (and colpomicroscope)
|
510(k) Number |
K073053 |
Device Name |
COLPO-MASTER |
Applicant |
UNITED PRODUCTS & INSTRUMENTS, INC. |
377 ROUTE 17 S |
HASBROUCK,
NJ
07604
|
|
Applicant Contact |
GEORGE MYERS |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
BOB MOSENKIS |
Regulation Number | 884.1630
|
Classification Product Code |
|
Date Received | 10/30/2007 |
Decision Date | 11/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|