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FDA 510(k)

DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED

K-Number: K911905 · 1991-07-02

ApplicantDeknatel, Inc.
Decision Date1991-07-02
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Deknatel, Inc.. It received FDA 510(k) clearance on 1991-07-02 under 510(k) number K911905. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED?

DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED is a medical device that received FDA 510(k) clearance on 1991-07-02. The listed applicant is Deknatel, Inc.. The 510(k) number is K911905.

When did DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED receive FDA 510(k) clearance?

DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED received FDA 510(k) clearance on 1991-07-02, under 510(k) number K911905.

Who is the listed applicant for DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED?

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

What is the FDA product code for DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED?

The FDA product code for DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED is GAW.

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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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