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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K983750
Device Name DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact CAMILLE MATLOCK
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact CAMILLE MATLOCK
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/23/1998
Decision Date 11/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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