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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 K952300
Device Name MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)
Applicant
Midas Rex Pneumatic Tools, Inc.
P.O. Box 16598
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Midas Rex Pneumatic Tools, Inc.
P.O. Box 16598
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number878.4820
Classification Product Code
GET  
Subsequent Product Code
GEY  
Date Received05/16/1995
Decision Date 05/26/1995
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
Predetermined Change
Control Plan Authorized		 No
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