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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.
 
DeviceTHE NEEDLE DESTROYER
Generic NameSharps needle destruction device
Regulation Number880.6210
ApplicantHealthcare Products Plus, Inc.
2119 N. Kenmore Ave.
Chicago, IL 60614
PMA NumberP960018
Supplement NumberS001
Date Received10/14/1998
Decision Date11/17/1998
Reclassified Date06/04/2018
Product Code MTV 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a change to the battery charger and the associated instructions for use.
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