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FDA 510(k)

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001

K-Number: K852271 · 1985-08-09

ApplicantCooperVision, Inc.
Decision Date1985-08-09
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1985-08-09 under 510(k) number K852271. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001?

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 is a medical device that received FDA 510(k) clearance on 1985-08-09. The listed applicant is CooperVision, Inc.. The 510(k) number is K852271.

When did CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 receive FDA 510(k) clearance?

CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 received FDA 510(k) clearance on 1985-08-09, under 510(k) number K852271.

Who is the listed applicant for CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001?

The FDA 510(k) record lists CooperVision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001?

The FDA product code for CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 is HQE.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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