FDA 510(k)

BIOCLEAN CHEMO SHIELD

K-Number: K081970 · 2009-03-11

Decision Date2009-03-11

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BIOCLEAN CHEMO SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Nitritex (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2009-03-11 under 510(k) number K081970. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCLEAN CHEMO SHIELD?

BIOCLEAN CHEMO SHIELD is a medical device that received FDA 510(k) clearance on 2009-03-11. The listed applicant is Nitritex (M) Sdn. Bhd.. The 510(k) number is K081970.

When did BIOCLEAN CHEMO SHIELD receive FDA 510(k) clearance?

BIOCLEAN CHEMO SHIELD received FDA 510(k) clearance on 2009-03-11, under 510(k) number K081970.

Who is the listed applicant for BIOCLEAN CHEMO SHIELD?

The FDA 510(k) record lists Nitritex (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCLEAN CHEMO SHIELD?

The FDA product code for BIOCLEAN CHEMO SHIELD is LZA.

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Other records listing Nitritex (M) Sdn. Bhd. as applicant

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Related Devices (Code: LZA)

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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.