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FDA 510(k)

THE NEW MCINTYRE I.A. HANDPIECE

K-Number: K854402 · 1985-12-30

ApplicantMicrosurgical Technology, Inc.
Decision Date1985-12-30
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

THE NEW MCINTYRE I.A. HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Microsurgical Technology, Inc.. It received FDA 510(k) clearance on 1985-12-30 under 510(k) number K854402. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE NEW MCINTYRE I.A. HANDPIECE?

THE NEW MCINTYRE I.A. HANDPIECE is a medical device that received FDA 510(k) clearance on 1985-12-30. The listed applicant is Microsurgical Technology, Inc.. The 510(k) number is K854402.

When did THE NEW MCINTYRE I.A. HANDPIECE receive FDA 510(k) clearance?

THE NEW MCINTYRE I.A. HANDPIECE received FDA 510(k) clearance on 1985-12-30, under 510(k) number K854402.

Who is the listed applicant for THE NEW MCINTYRE I.A. HANDPIECE?

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

What is the FDA product code for THE NEW MCINTYRE I.A. HANDPIECE?

The FDA product code for THE NEW MCINTYRE I.A. HANDPIECE is HMX.

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Other records listing Microsurgical Technology, 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.

K953959PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECESK946194WEE BAG O'MERCURYK943672PHACO NEEDLES AND TIPSK942403INFUSION CANNULAK934844INTER TIP TK854401THE NEW MOBILE TIP MCINTYRE CANNULA

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Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.

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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