510(k) K771933
K771933 is an FDA 510(k) premarket notification submitted by California Intraocular Lens for the device "CILCO ANTERIOR CHAMBER LENS". The FDA issued a decision of Substantially Equivalent on January 26, 1978. The device falls under product code HQL (Intraocular Lens), a Class III device regulated under 21 CFR 886.3600.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1978
- Date Received
- October 14, 1977
- 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