The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Midas Rex Motors, (midas I, Midas Ii & Convertible Models).
Device ID | K953434 |
510k Number | K953434 |
Device Name: | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) |
Classification | Motor, Drill, Pneumatic |
Applicant | MIDAS REX PNEUMATIC TOOLS, INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer MIDAS REX PNEUMATIC TOOLS, INC. 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-21 |
Decision Date | 1996-05-16 |
Summary: | summary |