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510(k) K031362

Device
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS
Applicant
LAC MAC, LTD.
510(k) number
K031362
Product code
KKX  
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-30
Date received
2003-02-20
Regulation
878.4370
Classification name
Drape, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY O STULL
Address
10907 Wareham Ct. Austin TX US 78739 78739

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KKX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.2023-10-25
K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company2023-05-18
K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba2021-07-30
K200238ControlRad Sterile CoverControlrad, Inc.2020-04-26
K163556MediClear PreOpCovalontechnologies, Inc.2017-09-14
K133080Plus Surgical Drapes (EO Sterilized), PMDB-XXXFoshan Nanhai Plus Medical Co, Ltd.2015-06-24
K141324HONGYU DISPOSABLE SURGICAL DRAPESWeihai Hongyu Nonwoven Fabric Products Co., Ltd.2015-04-14
K140195SURGICAL DRAPEGriffith-Lucas, LLC2014-09-10
K1403303M STERI-DRAPE FABRIC SURGICAL DRAPES3M Healthcare2014-08-18
K141438WHITNEY MEDICAL SOLUTIONS ESHIELDWhitney Medical Solutions2014-08-14
K1402503M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE3M Healthcare2014-07-25
K140064SURGISLEEVE WOUND PROTECTORCovidien2014-03-12
K131571AVD RIGHT RADIAL DRAPEAdvanced Vascular Dynamics2014-01-31
K130404TIBURON SURGICAL DRAPECardinal Health200, LLC2013-07-05
K121436DAS MEDICAL EQUIPMENT DRAPESDas Medical, LLC2013-06-06

Legacy Summary#

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FDA Review#

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