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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 K954076
Device Name MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
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 Received08/30/1995
Decision Date 10/18/1995
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
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