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 |