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FDA 510(k)

PARI I.S.-2

K-Number: K896984 · 1990-03-09

ApplicantDura Pharmaceuticals, Inc.
Decision Date1990-03-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent for Some Indications

Device Summary

PARI I.S.-2 is the device name listed in this FDA 510(k) record. The listed applicant is Dura Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1990-03-09 under 510(k) number K896984. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PARI I.S.-2?

PARI I.S.-2 is a medical device that received FDA 510(k) clearance on 1990-03-09. The listed applicant is Dura Pharmaceuticals, Inc.. The 510(k) number is K896984.

When did PARI I.S.-2 receive FDA 510(k) clearance?

PARI I.S.-2 received FDA 510(k) clearance on 1990-03-09, under 510(k) number K896984.

Who is the listed applicant for PARI I.S.-2?

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

What is the FDA product code for PARI I.S.-2?

The FDA product code for PARI I.S.-2 is CAF.

Other records listing Dura Pharmaceuticals, Inc. 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.

K936110ASPIREK894555PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED

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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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