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FDA 510(k)

MODEL 2001 PHACOEMULSIFIER ASPIRATOR

K-Number: K880968 · 1988-04-19

ApplicantMcghan Instrumed Corp.
Decision Date1988-04-19
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 2001 PHACOEMULSIFIER ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mcghan Instrumed Corp.. It received FDA 510(k) clearance on 1988-04-19 under 510(k) number K880968. 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 MODEL 2001 PHACOEMULSIFIER ASPIRATOR?

MODEL 2001 PHACOEMULSIFIER ASPIRATOR is a medical device that received FDA 510(k) clearance on 1988-04-19. The listed applicant is Mcghan Instrumed Corp.. The 510(k) number is K880968.

When did MODEL 2001 PHACOEMULSIFIER ASPIRATOR receive FDA 510(k) clearance?

MODEL 2001 PHACOEMULSIFIER ASPIRATOR received FDA 510(k) clearance on 1988-04-19, under 510(k) number K880968.

Who is the listed applicant for MODEL 2001 PHACOEMULSIFIER ASPIRATOR?

The FDA 510(k) record lists Mcghan Instrumed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 2001 PHACOEMULSIFIER ASPIRATOR?

The FDA product code for MODEL 2001 PHACOEMULSIFIER ASPIRATOR is HQE.

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Official Source

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

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