The following data is part of a premarket notification filed by Lsi Intl., Inc. with the FDA for Quantum Intersegmental Traction Table 400, 401, 400h,401h.
Device ID | K002390 |
510k Number | K002390 |
Device Name: | QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H |
Classification | Table, Physical Therapy, Multi Function |
Applicant | LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
Contact | James C Lanes |
Correspondent | James C Lanes LSI INTL., INC. 8849 BOND Overland Park, KS 66214 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-04 |
Decision Date | 2000-11-02 |
Summary: | summary |