The following data is part of a premarket notification filed by Twin City Surgical, Inc. with the FDA for Sims Chair.
Device ID | K861632 |
510k Number | K861632 |
Device Name: | SIMS CHAIR |
Classification | System, Isokinetic Testing And Evaluation |
Applicant | TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul, MN 55113 |
Contact | Wayne O Duescher |
Correspondent | Wayne O Duescher TWIN CITY SURGICAL, INC. 2800 N.FAIRVIEW AVE. St. Paul, MN 55113 |
Product Code | IKK |
CFR Regulation Number | 890.1925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-29 |
Decision Date | 1986-05-27 |