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FDA 510(k)

ROOTMAN ORBITAL SURGERY INSTRUMENT SET

K-Number: K842697 · 1984-08-07

ApplicantDowns Surgical , Ltd.
Decision Date1984-08-07
Product CodeHNR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROOTMAN ORBITAL SURGERY INSTRUMENT SET 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 1984-08-07 under 510(k) number K842697. The device is classified under product code HNR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOTMAN ORBITAL SURGERY INSTRUMENT SET?

ROOTMAN ORBITAL SURGERY INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 1984-08-07. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K842697.

When did ROOTMAN ORBITAL SURGERY INSTRUMENT SET receive FDA 510(k) clearance?

ROOTMAN ORBITAL SURGERY INSTRUMENT SET received FDA 510(k) clearance on 1984-08-07, under 510(k) number K842697.

Who is the listed applicant for ROOTMAN ORBITAL SURGERY INSTRUMENT SET?

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 ROOTMAN ORBITAL SURGERY INSTRUMENT SET?

The FDA product code for ROOTMAN ORBITAL SURGERY INSTRUMENT SET is HNR.

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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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