510(k) K832074

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA by CooperVision, Inc. — Product Code HKP

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