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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.
 
DeviceTHE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
Applicant
RedHawk Medical Products & Services LLC
p.o. box 53929
lafayette, LA 70505-3929
PMA NumberP010040
Date Received08/01/2001
Decision Date03/15/2002
Product Code
MTV
Docket Number 02M-0118
Notice Date 03/22/2002
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the disintegrator insulin needle destruction device. The device is indicated for insulin needle destruction for home use.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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