The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Midas Rex Motor.
Device ID | K972289 |
510k Number | K972289 |
Device Name: | MIDAS REX MOTOR |
Classification | Motor, Drill, Pneumatic |
Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
Contact | Michael Fowler |
Correspondent | Michael Fowler MIDAS REX PNEUMATIC TOOLS, INC. 3001 RACE ST. Fort Worth, TX 76111 -4117 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-19 |
Decision Date | 1997-09-12 |
Summary: | summary |