THE NEEDLE DESTROYER

FDA Premarket Approval P960018 S001

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.

Pre-market Approval Supplement Details

Approval for a change to the battery charger and the associated instructions for use.

DeviceTHE NEEDLE DESTROYER
Generic NameSharps Needle Destruction Device
ApplicantHEALTHCARE PRODUCTS PLUS, INC.
Date Received1998-10-14
Decision Date1998-11-17
PMAP960018
SupplementS001
Product CodeMTV 
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address HEALTHCARE PRODUCTS PLUS, INC. 2119 North Kenmore Ave. chicago, IL 60614

Supplemental Filings

Supplement NumberDateSupplement Type
P960018Original Filing
S001 1998-10-14 Normal 180 Day Track

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