The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Supercable Grip And Plate System.
Device ID | K072250 |
510k Number | K072250 |
Device Name: | SUPERCABLE GRIP AND PLATE SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
Contact | Vineet K Sarin |
Correspondent | Vineet K Sarin KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
Product Code | KTT |
Subsequent Product Code | HWC |
Subsequent Product Code | JDQ |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-13 |
Decision Date | 2007-11-09 |
Summary: | summary |