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FDA 510(k)

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS

K-Number: K982369 · 1998-08-24

ApplicantAllegiance Healthcare Corp.
Decision Date1998-08-24
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 1998-08-24 under 510(k) number K982369. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS?

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K982369.

When did CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS receive FDA 510(k) clearance?

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS received FDA 510(k) clearance on 1998-08-24, under 510(k) number K982369.

Who is the listed applicant for CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS?

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

What is the FDA product code for CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS?

The FDA product code for CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS is FYC.

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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.

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