TURKEL THORACENTESIS NEEDLE
FDA 510(k) clearance K921461 · decided 1992-07-30
Clearance details
- K-number
- K921461
- Device name
- TURKEL THORACENTESIS NEEDLE
- Applicant
- Symbiosis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-27
- Decision date
- 1992-07-30
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- GSS
- Device class
- 2
- Regulation number
- 866.3415
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.