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 |