Device Classification Name |
Bag, Intestine
|
510(k) Number |
K832318 |
Device Name |
ISOLATION BAG 3M |
Applicant |
3M COMPANY |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Correspondent |
3M COMPANY |
2724 SOUTH PECK RD. |
MONROVIA,
CA
91016
|
|
Regulation Number | 878.4100
|
Classification Product Code |
|
Date Received | 07/15/1983 |
Decision Date | 10/31/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|