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, Ii & Convertible Models).
Device ID | K952300 |
510k Number | K952300 |
Device Name: | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) |
Classification | Motor, Surgical Instrument, Pneumatic Powered |
Applicant | MIDAS REX PNEUMATIC TOOLS, INC. P.O. BOX 16598 Fort Worth, TX 76102 |
Contact | Richard A Hamer |
Correspondent | Richard A Hamer MIDAS REX PNEUMATIC TOOLS, INC. P.O. BOX 16598 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 | 1995-05-16 |
Decision Date | 1995-05-26 |