| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K091930 |
| Device Name |
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB |
| Applicant |
| Anchor Products Co. |
| 52 Official Rd. |
|
Addison,
IL
60101
|
|
| Applicant Contact |
GARY S THRUN |
| Correspondent |
| Anchor Products Co. |
| 52 Official Rd. |
|
Addison,
IL
60101
|
|
| Correspondent Contact |
GARY S THRUN |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 06/30/2009 |
| Decision Date | 09/23/2009 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|