The following data is part of a premarket notification filed by Midas Rex Pneumatic Tools, Inc. with the FDA for Midas Rex Telescoping System.
Device ID | K953433 |
510k Number | K953433 |
Device Name: | MIDAS REX TELESCOPING SYSTEM |
Classification | Motor, Surgical Instrument, Pneumatic Powered |
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 | GET |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-21 |
Decision Date | 1995-09-15 |