Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K982073 |
Device Name |
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM |
Applicant |
ANCHOR PRODUCTS CO. |
52 OFFICIAL RD. |
ADDISON,
IL
60101
|
|
Applicant Contact |
ROBERT H THRUM |
Correspondent |
ANCHOR PRODUCTS CO. |
52 OFFICIAL RD. |
ADDISON,
IL
60101
|
|
Correspondent Contact |
ROBERT H THRUM |
Regulation Number | 876.1500 |
Classification Product Code |
|
Date Received | 06/12/1998 |
Decision Date | 09/22/1998 |
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
|
Predetermined Change Control Plan Authorized |
No
|