510(k) K961658
K961658 is an FDA 510(k) premarket notification submitted by Intl. Ophthalmic Industries Corp. for the device "MEGATRON OPHTHALMIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 1996. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Intl. Ophthalmic Industries Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1996
- Date Received
- April 29, 1996
- 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