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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.
 
Trade NameTHE "DISINTEGRATOR" INSULIN NEEDLE DESTRUCTION DEVICE
Classification Namedevice, needle destruction
Generic Namesharps needle destruction device
ApplicantSAFEGUARD MEDICAL TECHNOLOGIES, LLC
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 
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