Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K041018 |
Device Name |
DRG SOFTRELEASE |
Applicant |
DOCTOR'S RESEARCH GROUP, INC. |
50 ALTAIR AVE. |
PLYMOUTH,
CT
06782
|
|
Applicant Contact |
EDWARD H GOLDMAN |
Correspondent |
DOCTOR'S RESEARCH GROUP, INC. |
50 ALTAIR AVE. |
PLYMOUTH,
CT
06782
|
|
Correspondent Contact |
EDWARD H GOLDMAN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/20/2004 |
Decision Date | 10/18/2004 |
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
|
|
|