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FDA 510(k)

HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER

K-Number: K122000 · 2012-12-12

ApplicantChangzhou Holymed Products Co., Ltd.
Decision Date2012-12-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Holymed Products Co., Ltd.. It received FDA 510(k) clearance on 2012-12-12 under 510(k) number K122000. 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 HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER?

HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Changzhou Holymed Products Co., Ltd.. The 510(k) number is K122000.

When did HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER receive FDA 510(k) clearance?

HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER received FDA 510(k) clearance on 2012-12-12, under 510(k) number K122000.

Who is the listed applicant for HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER?

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

What is the FDA product code for HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER?

The FDA product code for HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER is KKX.

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Other records listing Changzhou Holymed 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.

K210524Surgical MaskK121998HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED

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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