Sharps Terminator
FDA premarket approval P120018/S001 · decided 2018-02-16
Approval details
- PMA number
- P120018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sharps Terminator
- Generic name
- Sharps needle destruction device
- Applicant
- Sharps Terminator, LLC
- Date received
- 2017-05-25
- Decision date
- 2018-02-16
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Lubbock, TX
- Statement
- Approval for a manufacturing site located at Global Machining Industries, 28 Xinchang Road, 2nd Floor, Suzhou Industrial Park, Suzhou 21500, China, Manufacturing.
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