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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 K970398
Device Name SHARPS CONTAINER
Applicant
Custom Medical Plastics, Inc.
14315 C Cir.
Omaha,  NE  68144
Applicant Contact DANIEL R BROWN
Correspondent
Custom Medical Plastics, Inc.
14315 C Cir.
Omaha,  NE  68144
Correspondent Contact DANIEL R BROWN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/03/1997
Decision Date 07/03/1997
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
Predetermined Change
Control Plan Authorized		 No
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