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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 K946027
Device Name BIG PHIL
Applicant
Biomedical Waste Systems, Inc.
200 High St.
Boston,  MA  02110
Applicant Contact MICHAEL H KING
Correspondent
Biomedical Waste Systems, Inc.
200 High St.
Boston,  MA  02110
Correspondent Contact MICHAEL H KING
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/09/1994
Decision Date 01/26/1995
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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