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FDA 510(k)

MANUAL INSTRUMENTS

K-Number: K943937 · 1995-03-06

ApplicantPantheon Surgical Products
Decision Date1995-03-06
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MANUAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Surgical Products. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K943937. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL INSTRUMENTS?

MANUAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Pantheon Surgical Products. The 510(k) number is K943937.

When did MANUAL INSTRUMENTS receive FDA 510(k) clearance?

MANUAL INSTRUMENTS received FDA 510(k) clearance on 1995-03-06, under 510(k) number K943937.

Who is the listed applicant for MANUAL INSTRUMENTS?

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

What is the FDA product code for MANUAL INSTRUMENTS?

The FDA product code for MANUAL INSTRUMENTS is HRX.

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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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