510(k) K060046
- Device
- DERMASTREAM
- Applicant
- ENZYSURGE, LTD.
- 510(k) number
- K060046
- Product code
- NAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-02-27
- Date received
- 2006-01-06
- 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
- GEORGE J HATTUB
- Address
- 291 Hillside Ave. Somerset MA US 02726 02726
FDA Registration Numbers#
- 3004869142
- 3026263452
- 3009080375
- 3007307589
- 3044150131
- 3014368824
- 3017930281
- 1629057
- 3007007790
- 3039775399
- 3003887292
- 3008076203
- 1646434
- 3013557562
- 9710583
- 3011280379
- 3023809973
- 3006082230
- 3030088999
- 3004547763
- 8044178
- 3015515018
- 3042283853
- 3008384548
- 3013122778
- 3008044603
- 3012026312
- 3013517086
- 1423662
- 9611462
- 3013034812
- 3029875292
- 9614157
- 3008427684
- 3006506075
- 3025430795
- 3015456954
- 3038200636
- 3009931872
- 3016901080
- 3016515429
- 3041276890
- 3013154850
- 3004713654
- 3002807090
- 3017448136
- 3025430561
- 3015134081
- 3035523371
- 3013298431
- 3013354376
- 3009167225
- 3003403221
- 3013526501
- 9680357
- 3017846547
- 3008298053
- 3021228307
- 3042206168
- 3015416207
- 3029995180
- 3003799320
- 3045076483
- 3017264244
- 3042972928
- 3033520596
- 3010178296
- 3017911878
- 3016450032
- 3034669683
- 3003559457
- 3023339256
- 3007125336
- 3010160370
- 1287317
- 3015378469
- 9680091
- 3015058854
- 1018233
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 |
| 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 |
| 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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