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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K970965
Device Name MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
Applicant
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Applicant Contact MICHAEL FOWLER
Correspondent
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Correspondent Contact MICHAEL FOWLER
Regulation Number874.4250
Classification Product Code
ERL  
Date Received03/17/1997
Decision Date 04/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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