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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K961342
Device Name SHOE COVER, NON-STERILE
Applicant
Copioumed Intl., Inc.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Applicant Contact JANNA P TUCKER
Correspondent
Copioumed Intl., Inc.
19001 S. Richfield # 185
Green Valley,  AZ  85614
Correspondent Contact JANNA P TUCKER
Regulation Number878.4040
Classification Product Code
FXP  
Date Received03/20/1996
Decision Date 12/30/1996
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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