510(k) K914311
K914311 is an FDA 510(k) premarket notification submitted by Chiron Ophthalmics for the device "CHIROFLEX II LENS MICROSERT(TM)". The FDA issued a decision of Substantially Equivalent on January 27, 1992. The device falls under product code HQL (Intraocular Lens), a Class III device regulated under 21 CFR 886.3600. Chiron Ophthalmics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1992
- Date Received
- September 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraocular Lens
- Device Class
- Class III
- Regulation Number
- 886.3600
- Review Panel
- OP
- Submission Type