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FDA 510(k)

AGACHAMBER SPACER

K-Number: K101348 · 2011-04-29

ApplicantAga Plastic Ind. Com. Ltda.
Decision Date2011-04-29
Product CodeNVP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AGACHAMBER SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Aga Plastic Ind. Com. Ltda.. It received FDA 510(k) clearance on 2011-04-29 under 510(k) number K101348. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGACHAMBER SPACER?

AGACHAMBER SPACER is a medical device that received FDA 510(k) clearance on 2011-04-29. The listed applicant is Aga Plastic Ind. Com. Ltda.. The 510(k) number is K101348.

When did AGACHAMBER SPACER receive FDA 510(k) clearance?

AGACHAMBER SPACER received FDA 510(k) clearance on 2011-04-29, under 510(k) number K101348.

Who is the listed applicant for AGACHAMBER SPACER?

The FDA 510(k) record lists Aga Plastic Ind. Com. Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGACHAMBER SPACER?

The FDA product code for AGACHAMBER SPACER is NVP.

Related Clinical Trials

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Other records listing Aga Plastic Ind. Com. Ltda. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992995AROMATIC AND FLAVORED TONGUE DEPRESSOR

Related Devices (Code: NVP)

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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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