Device Classification Name |
Motor, Surgical Instrument, Pneumatic Powered
|
510(k) Number |
K953433 |
Device Name |
MIDAS REX TELESCOPING SYSTEM |
Applicant |
MIDAS REX PNEUMATIC TOOLS, INC. |
100 EAST 15TH ST. |
SUITE 320 |
FORT WORTH,
TX
76102
|
|
Applicant Contact |
RICHARD A HAMER |
Correspondent |
MIDAS REX PNEUMATIC TOOLS, INC. |
100 EAST 15TH ST. |
SUITE 320 |
FORT WORTH,
TX
76102
|
|
Correspondent Contact |
RICHARD A HAMER |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 07/21/1995 |
Decision Date | 09/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|