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FDA 510(k)

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

K-Number: K933595 · 1994-03-16

ApplicantOmega Surgical Instruments, Inc.
Decision Date1994-03-16
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BUR, SURGICAL, GENERAL & PLASTIC SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Omega Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K933595. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUR, SURGICAL, GENERAL & PLASTIC SURGERY?

BUR, SURGICAL, GENERAL & PLASTIC SURGERY is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Omega Surgical Instruments, Inc.. The 510(k) number is K933595.

When did BUR, SURGICAL, GENERAL & PLASTIC SURGERY receive FDA 510(k) clearance?

BUR, SURGICAL, GENERAL & PLASTIC SURGERY received FDA 510(k) clearance on 1994-03-16, under 510(k) number K933595.

Who is the listed applicant for BUR, SURGICAL, GENERAL & PLASTIC SURGERY?

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

What is the FDA product code for BUR, SURGICAL, GENERAL & PLASTIC SURGERY?

The FDA product code for BUR, SURGICAL, GENERAL & PLASTIC SURGERY is GFA.

Related Clinical Trials

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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Other records listing Omega Surgical Instruments, 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.

K941434K-WIRES AND STEINMANN PINSK933298SAW BLADE

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven Medical

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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