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FDA 510(k)

ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS

K-Number: K940230 · 1994-12-12

ApplicantInstratek, Inc.
Decision Date1994-12-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 1994-12-12 under 510(k) number K940230. 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 ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS?

ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Instratek, Inc.. The 510(k) number is K940230.

When did ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS receive FDA 510(k) clearance?

ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS received FDA 510(k) clearance on 1994-12-12, under 510(k) number K940230.

Who is the listed applicant for ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS?

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

What is the FDA product code for ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS?

The FDA product code for ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS is HRX.

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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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