FDA 510(k)

ULTRA-LINE RONGEUR

K-Number: K943635 · 1994-12-07

Decision Date1994-12-07

Product CodeHAE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ULTRA-LINE RONGEUR is the device name listed in this FDA 510(k) record. The listed applicant is V. Mueller Neuro/Spine. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K943635. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-LINE RONGEUR?

ULTRA-LINE RONGEUR is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is V. Mueller Neuro/Spine. The 510(k) number is K943635.

When did ULTRA-LINE RONGEUR receive FDA 510(k) clearance?

ULTRA-LINE RONGEUR received FDA 510(k) clearance on 1994-12-07, under 510(k) number K943635.

Who is the listed applicant for ULTRA-LINE RONGEUR?

The FDA 510(k) record lists V. Mueller Neuro/Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA-LINE RONGEUR?

The FDA product code for ULTRA-LINE RONGEUR is HAE.

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Related Devices (Code: HAE)

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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.