510(k) K831703
- Device
- Coverups
- Applicant
- THE UROLOGY GROUP
- 510(k) number
- K831703
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-03
- Date received
- 1983-05-25
- Regulation
- 878.4020
- Classification name
- Dressing, Wound, Occlusive
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004869142
- 3004022422
- 1648579
- 9616572
- 3013510154
- 1424263
- 3003403221
- 3039435289
- 3005619478
- 3030226294
- 3030446844
- 1925025
- 3015416207
- 3006142527
- 3030017177
- 9617592
- 3006065092
- 1926681
- 3007282994
- 3003807757
- 3010178296
- 3017846547
- 3005858760
- 3013354376
- 9680198
- 3006517436
- 3044466317
- 3016758972
- 2031094
- 3008242042
- 3008102042
- 3009640188
- 3011689956
- 3029995180
- 3008298053
- 9615662
- 3014437893
- 3014579161
- 3011280379
- 3008951115
- 3026331889
- 3008258694
- 3042261316
- 1319639
- 3027344214
- 3008824097
- 9611024
- 3006405073
- 3038988287
- 3008076203
- 3021013122
- 1480288
- 3004080548
- 3009504230
- 3034604687
- 3010374920
- 3010273867
- 3016674858
- 3008496560
- 3017448136
- 3035786168
- 1055236
- 3011210302
- 3011307048
- 3045857302
- 1720929
- 3009057691
- 1037885
- 3003559457
- 3010165567
- 3035767957
- 3034669683
- 1423537
- 3025771169
- 3004950768
- 3010339057
- 3005735974
- 3008427684
- 3012777736
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
| 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 |