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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Empty, For Collection & Processing Of Blood & Blood Components
510(k) Number K020753
Device Name DEROYAL SURGICAL, UMBILICUP
Applicant
Deroyal
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact AUDREY DANIELS
Correspondent
Deroyal
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact AUDREY DANIELS
Regulation Number864.9100
Classification Product Code
KSR  
Date Received03/07/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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