The following data is part of a premarket notification filed by Freeman Procedure Seminars with the FDA for Arthrostim Manipulator.
Device ID | K930431 |
510k Number | K930431 |
Device Name: | ARTHROSTIM MANIPULATOR |
Classification | Manipulator, Plunger-like Joint |
Applicant | FREEMAN PROCEDURE SEMINARS 4747 RIVER RD. N. Keizer, OR 97303 |
Contact | Michael D Freeman |
Correspondent | Michael D Freeman FREEMAN PROCEDURE SEMINARS 4747 RIVER RD. N. Keizer, OR 97303 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-26 |
Decision Date | 1994-07-15 |