Approval for the qcare needle management system. This device is a needle destruction device intended to be used in a home care environment to sever 1/2 inch hypodermic needles (gauges 28-29) from insulin syringes and store them for disposal.
Device | Q 103 NEEDLE MANAGEMENT SYSTEM |
Classification Name | Sharps Needle Destruction Device |
Generic Name | Sharps Needle Destruction Device |
Applicant | QCARE INTERNATIONAL, LLC. |
Date Received | 1998-05-26 |
Decision Date | 2000-12-21 |
Notice Date | 2001-01-03 |
PMA | P980020 |
Supplement | S |
Product Code | MTV |
Docket Number | 00M-1684 |
Advisory Committee | General Hospital |
Expedited Review | No |
Combination Product | No |
Applicant Address | QCARE INTERNATIONAL, LLC. 680 Atlanta Country Club Dr. marietta, GA 30067 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling |
Approval Order: | Approval Order |
Supplement Number | Date | Supplement Type |
---|---|---|
P980020 | Original Filing |