The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Brand Microvascular Anastomotic Coupler (27xx).
| Device ID | K861985 |
| 510k Number | K861985 |
| Device Name: | 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) |
| Classification | Device, Anastomotic, Microvascular |
| Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Contact | Charles W Opp |
| Correspondent | Charles W Opp 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
| Product Code | MVR |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-22 |
| Decision Date | 1986-12-04 |