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FDA 510(k)

STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE

K-Number: K924101 · 1994-04-11

ApplicantBaxter Healthcare Corp
Decision Date1994-04-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1994-04-11 under 510(k) number K924101. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE?

STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE is a medical device that received FDA 510(k) clearance on 1994-04-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K924101.

When did STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE receive FDA 510(k) clearance?

STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE received FDA 510(k) clearance on 1994-04-11, under 510(k) number K924101.

Who is the listed applicant for STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE?

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

What is the FDA product code for STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE?

The FDA product code for STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE is KKX.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: KKX)

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.

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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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