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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceQ 103 NEEDLE MANAGEMENT SYSTEM
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
Applicant
QCARE INTERNATIONAL, LLC.
680 atlanta country club dr.
marietta, GA 30067
PMA NumberP980020
Date Received05/26/1998
Decision Date12/21/2000
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 00M-1684
Notice Date 01/03/2001
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the qcare needle management system. This device is a needle destruction device intended to be used in a home care environment to sever 1/2 inch hypodermic needles (gauges 28-29) from insulin syringes and store them for disposal.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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