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FDA 510(k)

COOL-ZONE

K-Number: K963809 · 1996-11-20

ApplicantKappler USA
Decision Date1996-11-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOL-ZONE is the device name listed in this FDA 510(k) record. The listed applicant is Kappler USA. It received FDA 510(k) clearance on 1996-11-20 under 510(k) number K963809. 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 COOL-ZONE?

COOL-ZONE is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is Kappler USA. The 510(k) number is K963809.

When did COOL-ZONE receive FDA 510(k) clearance?

COOL-ZONE received FDA 510(k) clearance on 1996-11-20, under 510(k) number K963809.

Who is the listed applicant for COOL-ZONE?

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

What is the FDA product code for COOL-ZONE?

The FDA product code for COOL-ZONE is FYA.

Other records listing Kappler USA 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.

K992445MED-GUARD SURGEON'S GOWN

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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