The following data is part of a premarket notification filed by Trimed, Inc. with the FDA for Trimed Sterile Product.
Device ID | K091156 |
510k Number | K091156 |
Device Name: | TRIMED STERILE PRODUCT |
Classification | Plate, Fixation, Bone |
Applicant | TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
Contact | Kelli Anderson |
Correspondent | Kelli Anderson TRIMED, INC. 28337 MAITLAND LANE Saugus, CA 91350 |
Product Code | HRS |
Subsequent Product Code | HTY |
Subsequent Product Code | HWC |
Subsequent Product Code | JDS |
Subsequent Product Code | MBI |
Subsequent Product Code | NDL |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-21 |
Decision Date | 2009-07-15 |
Summary: | summary |