The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Precise Brand Internal Surgical Staples.
| Device ID | K921051 |
| 510k Number | K921051 |
| Device Name: | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES |
| Classification | Staple, Implantable |
| Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Contact | Willard D Larson |
| Correspondent | Willard D Larson 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1992-07-16 |