FDA 510(k)

HEM-O-LOK -- MODIFICATION

K-Number: K922186 · 1992-08-06

Decision Date1992-08-06

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HEM-O-LOK -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1992-08-06 under 510(k) number K922186. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEM-O-LOK -- MODIFICATION?

HEM-O-LOK -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-08-06. The listed applicant is Linvatec Corp.. The 510(k) number is K922186.

When did HEM-O-LOK -- MODIFICATION receive FDA 510(k) clearance?

HEM-O-LOK -- MODIFICATION received FDA 510(k) clearance on 1992-08-06, under 510(k) number K922186.

Who is the listed applicant for HEM-O-LOK -- MODIFICATION?

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 HEM-O-LOK -- MODIFICATION?

The FDA product code for HEM-O-LOK -- MODIFICATION is GDW.

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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.