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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
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
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 97M-0186
Notice Date 06/11/1997
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
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