510(k) K000416
K000416 is an FDA 510(k) premarket notification submitted by Retinalabs.Com for the device "TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001". The FDA issued a decision of Substantially Equivalent on May 8, 2000. The device falls under product code MPA (Endoilluminator), a Class II device regulated under 21 CFR 876.1500. Retinalabs.Com has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2000
- Date Received
- February 8, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type