Device Classification Name |
Cannula And Trocar, Suprapubic, Non-Disposable
|
510(k) Number |
K960400 |
Device Name |
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) |
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 | 876.5090
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/29/1996 |
Decision Date | 03/12/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|