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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 K943740
Device Name ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
Applicant
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Applicant Contact GARY P GARBIN
Correspondent
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Correspondent Contact GARY P GARBIN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/02/1994
Decision Date 12/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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