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FDA 510(k)

STRESS GUARD, MODEL HERDEV1

K-Number: K004008 · 2001-12-13

ApplicantHerbo Medex International, Inc.
Decision Date2001-12-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRESS GUARD, MODEL HERDEV1 is the device name listed in this FDA 510(k) record. The listed applicant is Herbo Medex International, Inc.. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K004008. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRESS GUARD, MODEL HERDEV1?

STRESS GUARD, MODEL HERDEV1 is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Herbo Medex International, Inc.. The 510(k) number is K004008.

When did STRESS GUARD, MODEL HERDEV1 receive FDA 510(k) clearance?

STRESS GUARD, MODEL HERDEV1 received FDA 510(k) clearance on 2001-12-13, under 510(k) number K004008.

Who is the listed applicant for STRESS GUARD, MODEL HERDEV1?

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

What is the FDA product code for STRESS GUARD, MODEL HERDEV1?

The FDA product code for STRESS GUARD, MODEL HERDEV1 is GZJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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