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FDA 510(k)

P3 UNIVERSAL PHACO HANDPIECE

K-Number: K972253 · 1997-07-29

ApplicantOdyssey Technologies, Inc.
Decision Date1997-07-29
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

P3 UNIVERSAL PHACO HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Odyssey Technologies, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K972253. 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 P3 UNIVERSAL PHACO HANDPIECE?

P3 UNIVERSAL PHACO HANDPIECE is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Odyssey Technologies, Inc.. The 510(k) number is K972253.

When did P3 UNIVERSAL PHACO HANDPIECE receive FDA 510(k) clearance?

P3 UNIVERSAL PHACO HANDPIECE received FDA 510(k) clearance on 1997-07-29, under 510(k) number K972253.

Who is the listed applicant for P3 UNIVERSAL PHACO HANDPIECE?

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

What is the FDA product code for P3 UNIVERSAL PHACO HANDPIECE?

The FDA product code for P3 UNIVERSAL PHACO HANDPIECE is HQC.

Related Clinical Trials

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Other records listing Odyssey Technologies, Inc. as applicant

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.

K972252VISTA UNIVERSAL HANDPIECE

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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