TAKY-SPIKE PLUS
FDA 510(k) clearance K974198 · decided 1997-12-22
Clearance details
- K-number
- K974198
- Device name
- TAKY-SPIKE PLUS
- Applicant
- Clinico
- Decision
- Substantially Equivalent
- Date received
- 1997-11-10
- Decision date
- 1997-12-22
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bad Hersfeld, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.