The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for Precise Flexistapler Circular Stapler, Series 398x.
| Device ID | K910897 |
| 510k Number | K910897 |
| Device Name: | PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X |
| Classification | Staple, Implantable |
| Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Contact | Charles W Opp |
| Correspondent | Charles W Opp 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-04 |
| Decision Date | 1991-04-01 |