FDA PMA
Approved
🇺🇸 United States
PMA: P970036
·
Supplement: S002
·
Decision Jul 29, 1998
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- NIC2800 NEEDLE DISPOSAL SYSTEM
- PMA Number
- P970036
- Supplement Number
- S002
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 29, 1998
- Date Received
- July 21, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.