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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 K944121
Device Name SHARPS CONTAINER 18 GALLON
Applicant
Bci, Inc.
170 Changebridge Rd.
Unit A4-2
Montyville,  NJ  07045
Applicant Contact ALAN LAROSEE
Correspondent
Bci, Inc.
170 Changebridge Rd.
Unit A4-2
Montyville,  NJ  07045
Correspondent Contact ALAN LAROSEE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/23/1994
Decision Date 01/27/1995
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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