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#
- 3011089435
- 3010165567
- 3012907824
- 8043484
- 3045058049
- 3010610950
- 3003835287
- 1526534
- 3011088743
- 3021033324
- 3018507299
- 3015937050
- 1480288
- 3014584671
- 3030626857
- 3017231740
- 3010419931
- 1000119796
- 3016674858
- 3010621964
- 3003887292
- 3007417776
- 1123137
- 3014579161
- 3010155648
- 9710020
- 3012391162
- 3039388855
- 3010160527
- 3012535730
- 3016758972
- 3000210785
- 1018120
- 3030421258
- 3013122778
- 2435946
- 3017911878
- 1060680
- 3011657181
- 3008770963
- 2435947
- 3022596459
- 3017297225
- 3043226252
- 3008384548
- 3016450032
- 1018233
- 3008676146
- 3036035308
- 3013525704
- 3011689956
- 3024088964
- 3002907620
- 3015378469
- 3013820501
- 1055236
- 3010034780
- 3014146451
- 3007605720
- 3010132111
- 3012314549
- 3033520596
- 3010785927
- 3026844237
- 3009039068
- 3031841433
- 3005113244
- 3022568093
- 3012465068
- 3012494290
- 9681544
- 3042272797
- 3041276890
- 3043041704
- 3009655869
- 3005083505
- 3004176951
- 1528440
- 3043503913
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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