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FDA 510(k)

ROTECNO 2000 SURGICAL GOWN

K-Number: K982059 · 1998-11-30

ApplicantEncompass Group, LLC
Decision Date1998-11-30
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROTECNO 2000 SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Encompass Group, LLC. It received FDA 510(k) clearance on 1998-11-30 under 510(k) number K982059. 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 ROTECNO 2000 SURGICAL GOWN?

ROTECNO 2000 SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Encompass Group, LLC. The 510(k) number is K982059.

When did ROTECNO 2000 SURGICAL GOWN receive FDA 510(k) clearance?

ROTECNO 2000 SURGICAL GOWN received FDA 510(k) clearance on 1998-11-30, under 510(k) number K982059.

Who is the listed applicant for ROTECNO 2000 SURGICAL GOWN?

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

What is the FDA product code for ROTECNO 2000 SURGICAL GOWN?

The FDA product code for ROTECNO 2000 SURGICAL GOWN is FYA.

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Other records listing Encompass Group, LLC 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.

K203085NOVA Patient Warming SystemK982058ROTECNO FR (FLUID RESISTANT) SURGICAL GOWNK760618PATIENT RESTRAINT

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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