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FDA 510(k)

BUDDE-HALO RETRACTOR

K-Number: K830332 · 1983-03-02

ApplicantOhio Medical Instrument Co., Inc.
Decision Date1983-03-02
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BUDDE-HALO RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1983-03-02 under 510(k) number K830332. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUDDE-HALO RETRACTOR?

BUDDE-HALO RETRACTOR is a medical device that received FDA 510(k) clearance on 1983-03-02. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K830332.

When did BUDDE-HALO RETRACTOR receive FDA 510(k) clearance?

BUDDE-HALO RETRACTOR received FDA 510(k) clearance on 1983-03-02, under 510(k) number K830332.

Who is the listed applicant for BUDDE-HALO RETRACTOR?

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

What is the FDA product code for BUDDE-HALO RETRACTOR?

The FDA product code for BUDDE-HALO RETRACTOR is GZT.

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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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