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FDA 510(k)

SURGICAL CHISEL/OSTEOTOME

K-Number: K894785 · 1989-08-18

ApplicantFdt Precision Machine Co., Inc.
Decision Date1989-08-18
Product CodeKDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL CHISEL/OSTEOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Fdt Precision Machine Co., Inc.. It received FDA 510(k) clearance on 1989-08-18 under 510(k) number K894785. The device is classified under product code KDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL CHISEL/OSTEOTOME?

SURGICAL CHISEL/OSTEOTOME is a medical device that received FDA 510(k) clearance on 1989-08-18. The listed applicant is Fdt Precision Machine Co., Inc.. The 510(k) number is K894785.

When did SURGICAL CHISEL/OSTEOTOME receive FDA 510(k) clearance?

SURGICAL CHISEL/OSTEOTOME received FDA 510(k) clearance on 1989-08-18, under 510(k) number K894785.

Who is the listed applicant for SURGICAL CHISEL/OSTEOTOME?

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

What is the FDA product code for SURGICAL CHISEL/OSTEOTOME?

The FDA product code for SURGICAL CHISEL/OSTEOTOME is KDG.

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Related Devices (Code: KDG)

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.

K952678STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KITAvail-Southwest DivisionK952200OMNI-JUGWaterstone Medical, Inc.K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.K872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSPorex MedicalK872092OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5Military Engineering, Inc.K842824CHERMEL BONE CHISELSCher Mel Corp.

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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