510(k) K914929
- Device
- LACERATION TRAY
- Applicant
- WESTMARK HOSPITAL SUPPLIES
- 510(k) number
- K914929
- Product code
- KKX
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1992-01-31
- Date received
- 1991-11-04
- 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
- MARJORIE L SCHMIDT
- Address
- 1253 Ramona SE Grand Rapids MI US 49507 49507
FDA Registration Numbers#
- 3006437555
- 3005369776
- 9616088
- 3009443860
- 3014579161
- 3011497662
- 9710018
- 2032112
- 3013298431
- 3008824097
- 3042940623
- 8030607
- 3027977504
- 3010493171
- 3009719225
- 8022129
- 3010432890
- 3013188547
- 3013497020
- 3006973666
- 3014421917
- 3011137372
- 3005675811
- 1721686
- 3015960676
- 3031757047
- 3016844398
- 3007082891
- 3011390076
- 3011237770
- 1319639
- 3009185973
- 3010487482
- 3004713654
- 1644312
- 1034084
- 3013077751
- 3035642068
- 3013429557
- 1037577
- 3018781093
- 3020331900
- 1721676
- 3010097171
- 3013868968
- 2183744
- 3043226252
- 9611594
- 1928237
- 3001650535
- 3017820152
- 3006891803
- 3006540014
- 3010684280
- 3011547453
- 3012143814
- 3006897899
- 2916714
- 3006787036
- 3005997949
- 3015153469
- 9611024
- 3017619652
- 3021274073
- 3018094310
- 3015895145
- 9681385
- 3045817901
- 9616876
- 9616096
- 2320762
- 3013960812
- 3013820501
- 1836161
- 8043817
- 1219930
- 1018470
- 3011140825
- 3006847952
- 3001003398
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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