FDA 510(k)

CERVICAL SELF-RETAINING RETRACTOR

K-Number: K935529 · 1994-03-22

ApplicantT. Korossurgical Instruments Corp.

Decision Date1994-03-22

Product CodeGZT

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CERVICAL SELF-RETAINING RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is T. Korossurgical Instruments Corp.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K935529. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVICAL SELF-RETAINING RETRACTOR?

CERVICAL SELF-RETAINING RETRACTOR is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is T. Korossurgical Instruments Corp.. The 510(k) number is K935529.

When did CERVICAL SELF-RETAINING RETRACTOR receive FDA 510(k) clearance?

CERVICAL SELF-RETAINING RETRACTOR received FDA 510(k) clearance on 1994-03-22, under 510(k) number K935529.

Who is the listed applicant for CERVICAL SELF-RETAINING RETRACTOR?

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

What is the FDA product code for CERVICAL SELF-RETAINING RETRACTOR?

The FDA product code for CERVICAL SELF-RETAINING RETRACTOR is GZT.

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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.