The following data is part of a premarket notification filed by Dhason Brothers, Inc. with the FDA for Thompson Type Rasp W/tommy Bar.
Device ID | K890161 |
510k Number | K890161 |
Device Name: | THOMPSON TYPE RASP W/TOMMY BAR |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | DHASON BROTHERS, INC. 1705 MERRIMAK DR. Hyattsville, MD 20783 |
Contact | Robert Dhason |
Correspondent | Robert Dhason DHASON BROTHERS, INC. 1705 MERRIMAK DR. Hyattsville, MD 20783 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-09 |
Decision Date | 1989-02-13 |