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FDA 510(k)

PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS

K-Number: K080629 · 2008-10-20

ApplicantPromedical Products Co., Ltd.
Decision Date2008-10-20
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS is the device name listed in this FDA 510(k) record. The listed applicant is Promedical Products Co., Ltd.. It received FDA 510(k) clearance on 2008-10-20 under 510(k) number K080629. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS?

PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS is a medical device that received FDA 510(k) clearance on 2008-10-20. The listed applicant is Promedical Products Co., Ltd.. The 510(k) number is K080629.

When did PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS receive FDA 510(k) clearance?

PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS received FDA 510(k) clearance on 2008-10-20, under 510(k) number K080629.

Who is the listed applicant for PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS?

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

What is the FDA product code for PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS?

The FDA product code for PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS is KKX.

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Other records listing Promedical Products Co., Ltd. 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.

K091097PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501K080627PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770AK042111PROMEDICAL SURGICAL GOWNSK042131PROMEDICAL SURGICAL DRAPESK042137PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS

Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, 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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