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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceNEEDLE-EASE TM 2501
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantMILLENIUM MEDICAL SUPPLY, INC.
THE WILLARD OFFICE BLDG.
1455 PENNSYLVANIA AVE., N.W.
WASHINGTON, D.C. 20004, DC 20004
PMA NumberP960044
Date Received12/06/1996
Decision Date03/06/1997
Reclassified Date 06/04/2018
Product Code MTV 
Docket Number 97M-0186
Notice Date 06/11/1997
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NEEDLE-EASE(TM) 2501. THIS DEVICE IS A SHARPS NEEDLE DESTRUCTION DEVICE THAT IS INTENDED FOR HOME USE BY DIABETICS TO REDUCE THE INCIDENCE OF NEEDLESTICKS BY THE INCINERATION OF 28-30 GAUGE NEEDLES, 29 AND 30 GAUGE DIABETIC "PEN TIPS" AND 23-26 GAUGE DIABETIC LANCETS.
Supplements:  S001 
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