TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
FDA 510(k) clearance K000416 · decided 2000-05-08
Clearance details
- K-number
- K000416
- Device name
- TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
- Applicant
- Retinalabs.Com
- Decision
- Substantially Equivalent
- Date received
- 2000-02-08
- Decision date
- 2000-05-08
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MPA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.