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FDA 510(k)

GRAFT GUARD

K-Number: K885136 · 1989-02-06

ApplicantSorex Medical
Decision Date1989-02-06
Product CodeLZM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GRAFT GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Sorex Medical. It received FDA 510(k) clearance on 1989-02-06 under 510(k) number K885136. The device is classified under product code LZM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAFT GUARD?

GRAFT GUARD is a medical device that received FDA 510(k) clearance on 1989-02-06. The listed applicant is Sorex Medical. The 510(k) number is K885136.

When did GRAFT GUARD receive FDA 510(k) clearance?

GRAFT GUARD received FDA 510(k) clearance on 1989-02-06, under 510(k) number K885136.

Who is the listed applicant for GRAFT GUARD?

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

What is the FDA product code for GRAFT GUARD?

The FDA product code for GRAFT GUARD is LZM.

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Other records listing Sorex Medical as applicant

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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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