NIC2800 NEEDLE DISPOSAL SYSTEM
FDA premarket approval P970036/S002 · decided 1998-07-29
Approval details
- PMA number
- P970036
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NIC2800 NEEDLE DISPOSAL SYSTEM
- Applicant
- Nic , Ltd.
- Date received
- 1998-07-21
- Decision date
- 1998-07-29
- Days to decision
- 8 days
- Decision code
- APPR
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Half Moon Bay, CA
- Statement
- Approval to market a battery operated version of the NiC 1800 Needle Disposal System. The device, as modified, will be marketed under the trade name NiC 2800 Needle Disposal System and is indicated for the disposal of standard plastic syring mounted hypodermic needles (19-28 gauge/up to 2" in length) in patient treatment and clinical laboratory settings.
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