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FDA 510(k)

R-BAR RETRACTOR

K-Number: K942415 · 1994-06-13

ApplicantLinvatec Corp.
Decision Date1994-06-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

R-BAR RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K942415. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-BAR RETRACTOR?

R-BAR RETRACTOR is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Linvatec Corp.. The 510(k) number is K942415.

When did R-BAR RETRACTOR receive FDA 510(k) clearance?

R-BAR RETRACTOR received FDA 510(k) clearance on 1994-06-13, under 510(k) number K942415.

Who is the listed applicant for R-BAR RETRACTOR?

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 R-BAR RETRACTOR?

The FDA product code for R-BAR RETRACTOR is GCJ.

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Other records listing Linvatec Corp. as applicant

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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