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FDA 510(k)

HYDRAGOWN

K-Number: K934664 · 1994-05-24

ApplicantMallinckrodt Group, Inc.
Decision Date1994-05-24
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDRAGOWN is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Group, Inc.. It received FDA 510(k) clearance on 1994-05-24 under 510(k) number K934664. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGOWN?

HYDRAGOWN is a medical device that received FDA 510(k) clearance on 1994-05-24. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K934664.

When did HYDRAGOWN receive FDA 510(k) clearance?

HYDRAGOWN received FDA 510(k) clearance on 1994-05-24, under 510(k) number K934664.

Who is the listed applicant for HYDRAGOWN?

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

What is the FDA product code for HYDRAGOWN?

The FDA product code for HYDRAGOWN is FYA.

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Other records listing Mallinckrodt Group, Inc. as applicant

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC

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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