Device Classification Name |
Clamp, Circumcision
|
510(k) Number |
K063429 |
Device Name |
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200 |
Applicant |
GENERIC MEDICAL DEVICE, INC. |
3906 ROSELAND ST. |
HOUSTON,
TX
77006
|
|
Applicant Contact |
MONICA MONTANEZ |
Correspondent |
GENERIC MEDICAL DEVICE, INC. |
3906 ROSELAND ST. |
HOUSTON,
TX
77006
|
|
Correspondent Contact |
MONICA MONTANEZ |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/13/2006 |
Decision Date | 01/17/2007 |
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
|
|
|