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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854462
Device Name MIDAS REX SURGICAL RUBBER DAM
Applicant
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Applicant Contact FOREST BARBER
Correspondent
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Correspondent Contact FOREST BARBER
Date Received11/06/1985
Decision Date 11/22/1985
Decision Substantially Equivalent (SESE)
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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