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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNEEDLE-EASE MODEL 3500
Classification Namedevice, needle destruction
ApplicantMILLENIUM MEDICAL SUPPLY, INC.
PMA NumberP960044
Supplement NumberS001
Date Received10/03/1997
Decision Date02/11/1998
Product Code
MTV
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified needle destruction device. The device, as modified, will be marketed under the trade name needle-ease(r) 3500 and is indicated for the disposal of standard plstic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices.
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