510(k) K063155
K063155 is an FDA 510(k) premarket notification submitted by Alcon Manufacturing, Ltd. for the device "MONARCH III IOL DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 27, 2007. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Alcon Manufacturing, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2007
- Date Received
- October 17, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Guide, Intraocular
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type