510(k) K020781
- Device
- WET CHAMBER
- Applicant
- KINETIC CONCEPTS, INC.
- 510(k) number
- K020781
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-06
- Date received
- 2002-03-11
- Regulation
- 878.4020
- Classification name
- Dressing, Wound, Occlusive
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUITH A HARBOUR
- Address
- P.O. Box 659508 San Antonio TX US 78265 78265
FDA Registration Numbers#
- 3007417776
- 1648579
- 3006517436
- 3030446844
- 3033451996
- 3016009624
- 3012026312
- 3006082230
- 3016159364
- 3016674858
- 3010374920
- 3015414875
- 3025430561
- 2122594
- 3015378469
- 3017297225
- 3023855650
- 3015515018
- 2953359
- 2951555
- 1643817
- 3004022422
- 3003965134
- 3002807090
- 3005460813
- 1018120
- 3013525704
- 3008392711
- 9680794
- 3007307589
- 3017390965
- 3045058049
- 3044777107
- 3013526501
- 1034876
- 3012090726
- 3014146451
- 3011280379
- 3017396949
- 3012809732
- 3017448136
- 3008044603
- 1047843
- 1000118068
- 3013530949
- 3023141635
- 3000268902
- 9710603
- 3009562494
- 3010273867
- 3010160527
- 3036035308
- 3017417635
- 3048248080
- 3009109670
- 3017930281
- 3030421258
- 3017036472
- 2435947
- 2110898
- 3013154850
- 3004869142
- 3018101380
- 3045076483
- 3012421607
- 3037918935
- 1423537
- 3008808082
- 3038274448
- 9680357
- 1287317
- 3013354376
- 3016615875
- 3015946389
- 3013517171
- 2135152
- 3011715978
- 3006633581
- 3034618336
Source Documents#
Other 510(k) Records For Product Code NAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | 2026-09-10 |
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | 2009-05-20 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | 2008-06-17 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | 2008-04-23 |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | 2006-02-27 |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | 2005-03-24 |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | 2000-01-31 |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | 1997-04-09 |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | 1996-04-29 |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | 1996-03-13 |
| K952203 | OTOSILK | Boston Medical Products, Inc. | 1995-07-31 |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | 1993-06-24 |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 |
Legacy Summary#
summary
FDA Review#
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