Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K992190 |
Device Name |
CORE POUCH |
Applicant |
CORE DYNAMICS, INC. |
11222 ST. JOHNS IND. PKWY. |
NORTH |
JACKSONVILLE,
FL
32246 -6675
|
|
Applicant Contact |
THOMAS M MCINTOSH |
Correspondent |
CORE DYNAMICS, INC. |
11222 ST. JOHNS IND. PKWY. |
NORTH |
JACKSONVILLE,
FL
32246 -6675
|
|
Correspondent Contact |
THOMAS M MCINTOSH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/29/1999 |
Decision Date | 09/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|