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FDA 510(k)

HOLE CHAMFERING DEVICE

K-Number: K841298 · 1984-04-25

ApplicantTechmedica, Inc.
Decision Date1984-04-25
Product CodeGFF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HOLE CHAMFERING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Techmedica, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K841298. The device is classified under product code GFF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLE CHAMFERING DEVICE?

HOLE CHAMFERING DEVICE is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Techmedica, Inc.. The 510(k) number is K841298.

When did HOLE CHAMFERING DEVICE receive FDA 510(k) clearance?

HOLE CHAMFERING DEVICE received FDA 510(k) clearance on 1984-04-25, under 510(k) number K841298.

Who is the listed applicant for HOLE CHAMFERING DEVICE?

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

What is the FDA product code for HOLE CHAMFERING DEVICE?

The FDA product code for HOLE CHAMFERING DEVICE is GFF.

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Other records listing Techmedica, 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.

K933935CKS POROUS COATED FEMORAL COMPONENTK932017TECHMEDICA CONTINUUM HIP WITH HA COATINGK931929TECHMEDICA CONTINUUM HIP SYSTEMK926387TECHMEDICA STANDARD CEMENTED HIP SYSTEMK925420TECHMEDICA STANDARD BIPOLAR SYSTEMK923808MULLER STRAIGHT STEM FEMORAL PROSTHESIS

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Related Devices (Code: GFF)

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.

K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.K950449SURGICAL BURTransidyne General Corp.K943758SURGICAL BURKomet MedicalK934583BURRSAmerican Medical Specialties, Inc.K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.K890090DANEK IRRIGATING BURR (DIB) SETDanek Medical, 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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