NEEDLE-EASE TM 2501
FDA premarket approval P960044 · decided 1997-03-06
Approval details
- PMA number
- P960044
- Trade name
- NEEDLE-EASE TM 2501
- Generic name
- Sharps needle destruction device
- Applicant
- Millenium Medical Supply, Inc.
- Date received
- 1996-12-06
- Decision date
- 1997-03-06
- Days to decision
- 90 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Washington, D.C. 20004, DC
- Statement
- APPROVAL FOR THE NEEDLE-EASE(TM) 2501. THIS DEVICE IS A SHARPS NEEDLE DESTRUCTION DEVICE THAT IS INTENDED FOR HOME USE BY DIABETICS TO REDUCE THE INCIDENCE OF NEEDLESTICKS BY THE INCINERATION OF 28-30 GAUGE NEEDLES, 29 AND 30 GAUGE DIABETIC "PEN TIPS" AND 23-26 GAUGE DIABETIC LANCETS.
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