NEEDLE-EASE MODEL 3500
FDA premarket approval P960044/S001 · decided 1998-02-11
Approval details
- PMA number
- P960044
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEEDLE-EASE MODEL 3500
- Generic name
- Sharps needle destruction device
- Applicant
- Millenium Medical Supply, Inc.
- Date received
- 1997-10-03
- Decision date
- 1998-02-11
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Washington, D.C. 20004, DC
- Statement
- Approval for a modified needle destruction device. The device, as modified, will be marketed under the trade name Needle-Ease(R) 3500 and is indicated for the disposal of standard plstic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices.
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