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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
3610 oakdale drive
mountain brook, AL 35223
PMA NumberP980015
Date Received05/08/1998
Decision Date08/06/1998
Product Code
MTV[ Registered Establishments with MTV ]
Docket Number 98M-0679
Notice Date 09/17/1998
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Sharpx(TM) Needle Destruction Unit. The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length. The unit is for use by healthcare professionals in out-patient and in-patient treatment settings and clinical laboratoreis.
Supplements: S001 S002 S003 S004 S005