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FDA 510(k)

PHACOFRAGMENTOR TIP

K-Number: K933627 · 1994-01-25

ApplicantM. Imonti and Associates Inc.,
Decision Date1994-01-25
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHACOFRAGMENTOR TIP is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1994-01-25 under 510(k) number K933627. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHACOFRAGMENTOR TIP?

PHACOFRAGMENTOR TIP is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K933627.

When did PHACOFRAGMENTOR TIP receive FDA 510(k) clearance?

PHACOFRAGMENTOR TIP received FDA 510(k) clearance on 1994-01-25, under 510(k) number K933627.

Who is the listed applicant for PHACOFRAGMENTOR TIP?

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

What is the FDA product code for PHACOFRAGMENTOR TIP?

The FDA product code for PHACOFRAGMENTOR TIP is HQC.

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Other records listing M. Imonti and Associates Inc., as applicant

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Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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