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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K935985
Device Name DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION
Original Applicant
DEROYAL INDUSTRIES, INC.
200 debusk ln.
powell,  TN  37849
Original Contact debra f manning
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/14/1993
Decision Date 12/21/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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