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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.
Generic Nameneedle destruction device
ApplicantNIC LTD.
PMA NumberP970036
Supplement NumberS002
Date Received07/21/1998
Decision Date07/29/1998
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market a battery operated version of the nic 1800 needle disposal system. The device, as modified, will be marketed under the trade name nic 2800 needle disposal system and is indicated for the disposal of standard plastic syring mounted hypodermic needles (19-28 gauge/up to 2" in length) in patient treatment and clinical laboratory settings.