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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 K955872
Device Name VOLMED OPERATION DRAPE
Applicant
Medal Intl. Sales Co., LLC
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Medal Intl. Sales Co., LLC
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/28/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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