Device Classification Name |
Clamp, Circumcision
|
510(k) Number |
K974286 |
Device Name |
CIRCUMCISION TRAY, CAT. NO. 70340 |
Applicant |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
SALISBURY,
MD
21801
|
|
Applicant Contact |
PARTHA BASUMALLIK |
Correspondent |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
SALISBURY,
MD
21801
|
|
Correspondent Contact |
PARTHA BASUMALLIK |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/14/1997 |
Decision Date | 12/12/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|