510(k) K921204
- Device
- DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
- Applicant
- TRINITY LABORATORIES, INC.
- 510(k) number
- K921204
- Product code
- KKX
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 1992-08-13
- Date received
- 1992-03-12
- 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
- PARTHA BASUMALLIK
- Address
- 201 Kiley Dr. Salisbury MD US 21801 21801
FDA Registration Numbers#
- 9681385
- 1000563940
- 3015173212
- 3030954512
- 1423537
- 3006425876
- 2029275
- 3013410562
- 3006538822
- 3028006458
- 9610612
- 9615551
- 3016844398
- 3034669683
- 3004713352
- 3008363989
- 2020282
- 2939520
- 1651395
- 3007289408
- 3013006775
- 3031841433
- 1423395
- 3004967902
- 3006540014
- 1625425
- 3015276780
- 3009443860
- 9680357
- 3011237770
- 3023228837
- 1420054
- 3003495693
- 3005997949
- 1047843
- 2032112
- 3002907620
- 9616088
- 3018094310
- 1048735
- 1319639
- 3015709932
- 3009185973
- 2182979
- 3001650535
- 1054241
- 3001675293
- 1928237
- 1123010
- 1065597
- 1423625
- 3010097171
- 1018470
- 3000268902
- 1032347
- 9710018
- 1721686
- 1219930
- 3007082891
- 3013188547
- 3004519921
- 1920664
- 9680284
- 2029015
- 3013421458
- 2031963
- 3007143236
- 3013429557
- 1422634
- 1123137
- 1055236
- 1313525
- 1037577
- 3013283620
- 3011554160
- 3004111573
- 1644312
- 1054069
- 3013600605
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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