510(k) K954239
K954239 is an FDA 510(k) premarket notification submitted by U.S. Iol, Inc. for the device "U.S. IOL PHACO HANDPIECE". The FDA issued a decision of Substantially Equivalent on Dec 8, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. U.S. Iol, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 1995
- Date Received
- Sep 11, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type
- 510(k)