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FDA 510(k)

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM

K-Number: K853709 · 1985-11-15

ApplicantDowns Surgical , Ltd.
Decision Date1985-11-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1985-11-15 under 510(k) number K853709. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM?

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM is a medical device that received FDA 510(k) clearance on 1985-11-15. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K853709.

When did A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM receive FDA 510(k) clearance?

A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM received FDA 510(k) clearance on 1985-11-15, under 510(k) number K853709.

Who is the listed applicant for A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM?

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

What is the FDA product code for A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM?

The FDA product code for A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM is HRS.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: HRS)

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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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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