Device Classification Name |
Coagulator, Culdoscopic (And Accessories)
|
510(k) Number |
K924148 |
Device Name |
DIAMOND-SHARP(R) TROCARS |
Applicant |
SNOWDEN-PENCER |
5175 SOUTH ROYAL ATLANTA DR. |
TUCKER,
GA
30084
|
|
Applicant Contact |
JULIE A STEPHENS |
Correspondent |
SNOWDEN-PENCER |
5175 SOUTH ROYAL ATLANTA DR. |
TUCKER,
GA
30084
|
|
Correspondent Contact |
JULIE A STEPHENS |
Regulation Number | 884.4160
|
Classification Product Code |
|
Date Received | 08/18/1992 |
Decision Date | 02/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|