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FDA 510(k)

STACKHOUSE LENS HOOD, MODEL SA-700/FS

K-Number: K003194 · 2000-10-26

ApplicantStackhouse, Inc.
Decision Date2000-10-26
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STACKHOUSE LENS HOOD, MODEL SA-700/FS is the device name listed in this FDA 510(k) record. The listed applicant is Stackhouse, Inc.. It received FDA 510(k) clearance on 2000-10-26 under 510(k) number K003194. 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 STACKHOUSE LENS HOOD, MODEL SA-700/FS?

STACKHOUSE LENS HOOD, MODEL SA-700/FS is a medical device that received FDA 510(k) clearance on 2000-10-26. The listed applicant is Stackhouse, Inc.. The 510(k) number is K003194.

When did STACKHOUSE LENS HOOD, MODEL SA-700/FS receive FDA 510(k) clearance?

STACKHOUSE LENS HOOD, MODEL SA-700/FS received FDA 510(k) clearance on 2000-10-26, under 510(k) number K003194.

Who is the listed applicant for STACKHOUSE LENS HOOD, MODEL SA-700/FS?

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

What is the FDA product code for STACKHOUSE LENS HOOD, MODEL SA-700/FS?

The FDA product code for STACKHOUSE LENS HOOD, MODEL SA-700/FS 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 Stackhouse, Inc. 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.

K000605STACKHOUSE LENS HOOD, MODEL SA-700/FK001082STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100K944116FREEDOM ASPIRATOR, MODEL 6000

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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