Q 103 NEEDLE MANAGEMENT SYSTEM
FDA premarket approval P980020 · decided 2000-12-21
Approval details
- PMA number
- P980020
- Trade name
- Q 103 NEEDLE MANAGEMENT SYSTEM
- Generic name
- Sharps needle destruction device
- Applicant
- Qcare International, LLC
- Date received
- 1998-05-26
- Decision date
- 2000-12-21
- Days to decision
- 940 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Marietta, GA
- Statement
- 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.
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