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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 K952463
Device Name GS & GS20 SURGICAL TOOL SYSTEM
Applicant
MIDAS REX PNEUMATIC TOOLS, INC.
3001 RACE ST.
FORT WORTH,  TX  76111 -4117
Applicant Contact FOREST BARBER, JR.
Correspondent
MIDAS REX PNEUMATIC TOOLS, INC.
3001 RACE ST.
FORT WORTH,  TX  76111 -4117
Correspondent Contact FOREST BARBER, JR.
Regulation Number878.4820
Classification Product Code
GET  
Date Received05/26/1995
Decision Date 07/17/1995
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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