510(k) K000420
K000420 is an FDA 510(k) premarket notification submitted by Retinalabs.Com for the device "SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003". The FDA issued a decision of Substantially Equivalent on May 8, 2000. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. 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
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type