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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K902715
Device Name SURGICAL TOWEL
Applicant
Aztec Medical, Inc.
3212 Bishop Dr., Suite 400
Arlington,  TX  76010
Applicant Contact TERRY RAMSEY
Correspondent
Aztec Medical, Inc.
3212 Bishop Dr., Suite 400
Arlington,  TX  76010
Correspondent Contact TERRY RAMSEY
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/20/1990
Decision Date 09/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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