Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K932118 |
Device Name |
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET |
Applicant |
CORE DYNAMICS, INC. |
11222-4 ST. JOHNS |
INDUSTRIAL PARKWAY |
JACKSONVILLE,
FL
32246
|
|
Applicant Contact |
BILL DENNIS |
Correspondent |
CORE DYNAMICS, INC. |
11222-4 ST. JOHNS |
INDUSTRIAL PARKWAY |
JACKSONVILLE,
FL
32246
|
|
Correspondent Contact |
BILL DENNIS |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 05/03/1993 |
Decision Date | 03/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|