Submission Details
| 510(k) Number | K832074 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 28, 1983 |
| Decision Date | August 01, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
Aug 1983
Decision
34d
Days
Class 2
Risk
About This 510(k) Submission
K832074 is an FDA 510(k) clearance for the CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1983, 34 days after receiving the submission on June 28, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.
Device Classification
| Product Code | HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4150 |
Manufacturer
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