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#
- 1423537
- 3008656870
- 3011987967
- 3017297225
- 3006538822
- 3012535730
- 3034669683
- 3009344179
- 3015200795
- 1038963
- 3006506075
- 3031841433
- 3014747754
- 3007028040
- 3017417635
- 9616572
- 3016920640
- 1052728
- 9680198
- 1018120
- 1047843
- 3008770963
- 3013154850
- 1054241
- 3038274448
- 3012441818
- 3017633586
- 3020188747
- 3022085015
- 1648579
- 1528440
- 3029995180
- 3021630959
- 9680284
- 3029894475
- 3025413691
- 3010160527
- 1219795
- 9617266
- 3022596459
- 3008386507
- 3033273018
- 3043503913
- 3010881832
- 3044466317
- 3041276890
- 3006606901
- 3015134081
- 3021228307
- 3015416207
- 3007125336
- 3013960199
- 3033451996
- 3012309743
- 3015277818
- 3006142527
- 1061124
- 1038758
- 3014368824
- 3017220525
- 3027517726
- 1926681
- 3015821396
- 3009109670
- 3010288357
- 3006371704
- 3030733800
- 3016904853
- 2320762
- 9710583
- 3038988287
- 3002807310
- 3013034812
- 3015745029
- 3015140199
- 3004713654
- 3011657181
- 3017235663
- 3010034780
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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