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FDA 510(k)

LIMITED REUSE BLADES

K-Number: K943985 · 1994-11-07

ApplicantLinvatec Corp.
Decision Date1994-11-07
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIMITED REUSE BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K943985. 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 LIMITED REUSE BLADES?

LIMITED REUSE BLADES is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Linvatec Corp.. The 510(k) number is K943985.

When did LIMITED REUSE BLADES receive FDA 510(k) clearance?

LIMITED REUSE BLADES received FDA 510(k) clearance on 1994-11-07, under 510(k) number K943985.

Who is the listed applicant for LIMITED REUSE BLADES?

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

What is the FDA product code for LIMITED REUSE BLADES?

The FDA product code for LIMITED REUSE BLADES 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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