510(k) K981571
K981571 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "MONARCH IOL DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Alcon Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1998
- Date Received
- May 4, 1998
- 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