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FDA 510(k)

NON-STERILE MASKS AND CAPS

K-Number: K892118 · 1989-04-20

ApplicantParamount Products, Inc.
Decision Date1989-04-20
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE MASKS AND CAPS is the device name listed in this FDA 510(k) record. The listed applicant is Paramount Products, Inc.. It received FDA 510(k) clearance on 1989-04-20 under 510(k) number K892118. 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 NON-STERILE MASKS AND CAPS?

NON-STERILE MASKS AND CAPS is a medical device that received FDA 510(k) clearance on 1989-04-20. The listed applicant is Paramount Products, Inc.. The 510(k) number is K892118.

When did NON-STERILE MASKS AND CAPS receive FDA 510(k) clearance?

NON-STERILE MASKS AND CAPS received FDA 510(k) clearance on 1989-04-20, under 510(k) number K892118.

Who is the listed applicant for NON-STERILE MASKS AND CAPS?

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

What is the FDA product code for NON-STERILE MASKS AND CAPS?

The FDA product code for NON-STERILE MASKS AND CAPS is FYA.

Related Clinical Trials

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Other records listing Paramount Products, 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.

K891017PATIENT EXAMINATION GLOVE

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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