Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PLAQ-ATAQ-I

K-Number: K980995 · 1998-08-20

ApplicantEthicare
Decision Date1998-08-20
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLAQ-ATAQ-I is the device name listed in this FDA 510(k) record. The listed applicant is Ethicare. It received FDA 510(k) clearance on 1998-08-20 under 510(k) number K980995. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAQ-ATAQ-I?

PLAQ-ATAQ-I is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Ethicare. The 510(k) number is K980995.

When did PLAQ-ATAQ-I receive FDA 510(k) clearance?

PLAQ-ATAQ-I received FDA 510(k) clearance on 1998-08-20, under 510(k) number K980995.

Who is the listed applicant for PLAQ-ATAQ-I?

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

What is the FDA product code for PLAQ-ATAQ-I?

The FDA product code for PLAQ-ATAQ-I is EFW.

Related Devices (Code: EFW)

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.

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.

↑