510(k) K091133
- Device
- APLION TOPICAL CARE SYSTEM
- Applicant
- APLION MEDICAL,LLC
- 510(k) number
- K091133
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-20
- Date received
- 2009-04-20
- 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
- CURTIS JENSEN
- Address
- 2425 S. 900 W. Salt Lake City UT US 84119 84119
FDA Registration Numbers#
- 3008806809
- 3000210785
- 1926681
- 3032911850
- 3035523371
- 1038963
- 1287317
- 3015745029
- 3016920640
- 3008044603
- 3004681519
- 1720929
- 3004135030
- 3016758972
- 3014195785
- 3012680643
- 2135339
- 3010305275
- 3009486864
- 3003799320
- 3016615875
- 3041329419
- 9680357
- 3031582449
- 3005113244
- 3026263452
- 3010621964
- 1018233
- 1060680
- 3023191945
- 3006517436
- 3030333982
- 3007327603
- 3023316
- 3010763707
- 3044466317
- 1648579
- 3007607706
- 3014312726
- 3008132398
- 2530957
- 3002468342
- 3012084379
- 3017036472
- 3039775399
- 3041276890
- 3008485841
- 3015134081
- 3033520596
- 3015937050
- 3008374791
- 3031582434
- 3030394731
- 1420763
- 3023141635
- 3007125968
- 3021013122
- 3005619478
- 3010610950
- 3005761322
- 3008496560
- 3042953785
- 3030067857
- 8010803
- 2648727
- 3016096140
- 3021082429
- 3011715922
- 3037031822
- 3027977504
- 3007735241
- 3043503913
- 3010824458
- 3009931872
- 3004857344
- 3010160527
- 3018101380
- 1000317571
- 3007282994
Source Documents#
Other 510(k) Records For Product Code NAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | 2011-03-03 |
| 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 |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | 2002-05-06 |
| 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 |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | 1991-03-06 |
Legacy Summary#
summary
FDA Review#
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