510(k) K832074
K832074 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA". The FDA issued a decision of Substantially Equivalent on August 1, 1983. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. CooperVision, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1983
- Date Received
- June 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type