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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number878.4820
Classification Product Code
GET  
Date Received07/21/1995
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
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