The following data is part of a premarket notification filed by Intl. Management Services, Inc. with the FDA for Imsi/metripond Gripper Plate.
Device ID | K843370 |
510k Number | K843370 |
Device Name: | IMSI/METRIPOND GRIPPER PLATE |
Classification | Plate, Fixation, Bone |
Applicant | INTL. MANAGEMENT SERVICES, INC. 134 SO. 13TH. STREET SUITE 1101 Lincoln , NE 68508 - |
Contact | Ted L Algaier |
Correspondent | Ted L Algaier INTL. MANAGEMENT SERVICES, INC. 134 SO. 13TH. STREET SUITE 1101 Lincoln , NE 68508 - |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-28 |
Decision Date | 1985-01-23 |