ELECTRODE NEEDLES
FDA 510(k) clearance K990015 · decided 1999-05-27
Clearance details
- K-number
- K990015
- Device name
- ELECTRODE NEEDLES
- Applicant
- Technomed Europe
- Decision
- Substantially Equivalent
- Date received
- 1999-01-04
- Decision date
- 1999-05-27
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- IKT
- Device class
- 2
- Regulation number
- 890.1385
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- 6191 Bg Beek, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.