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FDA 510(k)

STRYKER STERI-SHIELD SURGICAL APPAREL

K-Number: K944393 · 1995-08-28

ApplicantStryker Corp.
Decision Date1995-08-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRYKER STERI-SHIELD SURGICAL APPAREL is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K944393. 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 STRYKER STERI-SHIELD SURGICAL APPAREL?

STRYKER STERI-SHIELD SURGICAL APPAREL is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Stryker Corp.. The 510(k) number is K944393.

When did STRYKER STERI-SHIELD SURGICAL APPAREL receive FDA 510(k) clearance?

STRYKER STERI-SHIELD SURGICAL APPAREL received FDA 510(k) clearance on 1995-08-28, under 510(k) number K944393.

Who is the listed applicant for STRYKER STERI-SHIELD SURGICAL APPAREL?

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

What is the FDA product code for STRYKER STERI-SHIELD SURGICAL APPAREL?

The FDA product code for STRYKER STERI-SHIELD SURGICAL APPAREL is FYA.

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Other records listing Stryker Corp. as applicant

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K230045HipCheckK191259Stryker CrossFlow Integrated Arthroscopy PumpK182359HipCheckK122113MEMORY METAL STAPLES, EASYCLIPK122053SHAPEMATCH CUTTING GUIDEK122284HOFFMANN 3

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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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