510(k) K962003
- Device
- TUAT SPLATTER CONTROL SHIELD SCS-300
- Applicant
- TAUT, INC.
- 510(k) number
- K962003
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-18
- Date received
- 1996-05-22
- 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
- GLENN B MILLER
- Address
- 2571 Kaneville Ct. P.O. Box 326 Geneva IL US 60134 60134
FDA Registration Numbers#
- 3012421607
- 9616088
- 1061124
- 1032347
- 3007886583
- 3013188547
- 3006437555
- 8043817
- 3011106828
- 3011497662
- 3004361903
- 3011554160
- 2022435
- 1721676
- 1424263
- 3030626857
- 1920664
- 3011547453
- 3006425876
- 3011137372
- 3006891803
- 1211998
- 9710018
- 3001650535
- 3008824097
- 3017937325
- 3012143814
- 1123137
- 3001124136
- 2648727
- 3014579161
- 1651395
- 1066741
- 1036836
- 3034669683
- 3013298431
- 3027977504
- 3004713654
- 2183744
- 3008363989
- 3010487482
- 3013960812
- 3021274073
- 1000563940
- 3044026004
- 1417592
- 9616876
- 3004122598
- 3007007790
- 2427500
- 3015276780
- 1060680
- 3000268902
- 3010305275
- 3003495693
- 3003542872
- 3013466775
- 3001003398
- 3011237770
- 8020785
- 2032112
- 3043226252
- 3013410562
- 3007082891
- 3013557562
- 3023228837
- 3010432890
- 3006897899
- 3028006458
- 3010041511
- 3013421458
- 1928237
- 3008502431
- 3002907620
- 1721686
- 3013820501
- 1836161
- 2020282
- 1055236
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | 2023-10-25 |
| K222578 | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | 2023-05-18 |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | 2021-07-30 |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | 2020-04-26 |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | 2017-09-14 |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | 2015-06-24 |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2015-04-14 |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | 2014-09-10 |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | 2014-08-18 |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | 2014-08-14 |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | 2014-07-25 |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | 2014-03-12 |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | 2014-01-31 |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | 2013-07-05 |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | 2013-06-06 |
Legacy Summary#
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FDA Review#
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