The following data is part of a premarket notification filed by 3m Company with the FDA for Isolation Bag 3m.
| Device ID | K832318 |
| 510k Number | K832318 |
| Device Name: | ISOLATION BAG 3M |
| Classification | Bag, Intestine |
| Applicant | 3M COMPANY 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Product Code | KGY |
| CFR Regulation Number | 878.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-15 |
| Decision Date | 1983-10-31 |