NEEDLE ZAP
FDA premarket approval P010065/S002 · decided 2004-02-05
Approval details
- PMA number
- P010065
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEEDLE ZAP
- Generic name
- Sharps needle destruction device
- Applicant
- E Med Future
- Date received
- 2003-11-12
- Decision date
- 2004-02-05
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Millersburg, OH
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT FRANTZ MEDICAL DEVELOPMENT, LTD., MENTOR, OHIO.
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