510(k) K042137
- Device
- PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
- Applicant
- PROMEDICAL PRODUCTS CO., LTD.
- 510(k) number
- K042137
- Product code
- KKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-10-05
- Date received
- 2004-08-09
- 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
- BOYD HARRIS
- Address
- 125 Clements Ave. Starkville MS US 39759 39759
FDA Registration Numbers#
- 1123137
- 3034669683
- 3006723155
- 3030626857
- 3009600453
- 3028006458
- 3019924
- 9680794
- 3005595283
- 3006437555
- 2427500
- 1060680
- 2031963
- 1625425
- 1061124
- 8043817
- 9611024
- 1065597
- 3010041511
- 3010432890
- 9681385
- 3015859709
- 3013429557
- 3015173212
- 3004111573
- 3012966700
- 3008824097
- 8020785
- 3012026312
- 3013443304
- 3003495693
- 3004519921
- 9611594
- 1313525
- 3016844398
- 3001124136
- 2320762
- 9616876
- 3007886583
- 1054241
- 3013006775
- 3013820501
- 3003542872
- 2183744
- 1043549
- 3009443860
- 1032347
- 3013960812
- 9710018
- 3011500469
- 3006897899
- 3015960676
- 3004713654
- 1928237
- 3010097171
- 1836161
- 3021274073
- 1036836
- 3002907620
- 3004713352
- 3027977504
- 3043226252
- 1319639
- 3015709932
- 3006973666
- 3006538822
- 3009542933
- 1420054
- 1037885
- 1424263
- 1211998
- 1018470
- 3001675293
- 3008363989
- 1043214
- 3012143814
- 1030451
- 3012421607
- 1423395
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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