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#
- 3014666579
- 3008656870
- 3022085015
- 3021013122
- 3008132398
- 3009109670
- 1048735
- 3006142527
- 1047843
- 3013298431
- 1000317571
- 3042953785
- 3005761322
- 3023855650
- 3007735241
- 3007307589
- 3044026004
- 3021228307
- 3008384548
- 1038758
- 3012309743
- 1420763
- 3008572121
- 3016445778
- 1319639
- 2320961
- 3017036472
- 9680143
- 3008676146
- 1930027
- 3012034017
- 3011191255
- 3010452421
- 3023141635
- 1038963
- 3027344214
- 8044178
- 3042972928
- 3012084379
- 3025413691
- 3012314549
- 3030088999
- 3017930281
- 3007648359
- 3003835287
- 1643817
- 3016096140
- 9611462
- 3006633581
- 1644312
- 9710020
- 3009057691
- 3011582224
- 3007327603
- 3008298053
- 3006802076
- 3015142802
- 3007048057
- 3008262278
- 3013034812
- 3016769192
- 3007966889
- 3005841027
- 3010339057
- 3015821396
- 3008258694
- 3010131137
- 3011248163
- 3010610950
- 3010155648
- 3005113244
- 3010419931
- 3007594734
- 3032812695
- 3015174114
- 3015456954
- 3043041704
- 3027517726
- 3007605720
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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