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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNIC2800 NEEDLE DISPOSAL SYSTEM
ApplicantNic , Ltd.
320 Fairway Dr.
Half Moon Bay, CA 94019
PMA NumberP970036
Supplement NumberS002
Date Received07/21/1998
Decision Date07/29/1998
Reclassified Date06/04/2018
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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