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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K900388
Device Name MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
Applicant
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111 -4117
Applicant Contact BARBER, JR
Correspondent
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111 -4117
Correspondent Contact BARBER, JR
Regulation Number882.4310
Classification Product Code
HBE  
Date Received01/29/1990
Decision Date 05/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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