INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
FDA 510(k) clearance K983200 · decided 1998-12-11
Clearance details
- K-number
- K983200
- Device name
- INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
- Applicant
- Ximed/Prosure/Injectx
- Decision
- Substantially Equivalent
- Date received
- 1998-09-14
- Decision date
- 1998-12-11
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GAA
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.