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FDA 510(k)

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)

K-Number: K932003 · 1993-06-11

ApplicantNational Healthcare Linen Service
Decision Date1993-06-11
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) is the device name listed in this FDA 510(k) record. The listed applicant is National Healthcare Linen Service. It received FDA 510(k) clearance on 1993-06-11 under 510(k) number K932003. 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 N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)?

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) is a medical device that received FDA 510(k) clearance on 1993-06-11. The listed applicant is National Healthcare Linen Service. The 510(k) number is K932003.

When did N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) receive FDA 510(k) clearance?

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) received FDA 510(k) clearance on 1993-06-11, under 510(k) number K932003.

Who is the listed applicant for N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)?

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

What is the FDA product code for N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)?

The FDA product code for N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) is FYA.

Related Clinical Trials

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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Other records listing National Healthcare Linen Service 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.

K936210NPACK924055N-PACK923688N-PAC

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

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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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