510(k) K112131
- Device
- NEODYNE DRESSING
- Applicant
- NEODYNE BIOSCIENCES, INC.
- 510(k) number
- K112131
- Product code
- MDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-29
- Date received
- 2011-07-26
- Regulation
- 878.4025
- Classification name
- Elastomer, Silicone, For Scar Management
- 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
- PEGGY MCLAUGHLIN
- Address
- 127 Independence Dr. Menlo Park CA US 94025 94025
FDA Registration Numbers#
- 3009843176
- 3038222326
- 3010256218
- 3031841907
- 3021013122
- 3034669683
- 3009317711
- 3016450032
- 3012084379
- 3005621808
- 3008044603
- 3007289408
- 2431069
- 3010822231
- 3012706495
- 3030726486
- 3038310422
- 3010380285
- 8022978
- 3006897996
- 3007607706
- 3006227741
- 3005761322
- 3009057691
- 3033536319
- 2529394
- 2031444
- 3016585381
- 9616572
- 3001744192
- 3031582434
- 3042283853
- 3004967086
- 3005779557
- 3030067857
- 3043138901
- 3036893546
- 3008951066
- 3021821373
- 1048735
- 3022754162
- 3018101380
- 3016758972
- 2182979
- 3004537835
- 3016245348
- 3012034017
- 1062964
- 3014982332
- 3021630959
- 3003897287
- 3023662442
- 3038624837
- 1058063
- 3008242042
- 3025413691
- 1219795
- 3011248163
- 3005951403
- 3013037032
- 3013496867
- 3023548698
- 3013057573
- 3007841320
- 8023033
- 3035786168
- 3009192857
- 3003348807
- 3032812695
- 2950792
- 3012818008
- 3023141635
- 1000641183
- 3025430561
- 3044517693
- 3007125336
- 3036035308
- 3003828812
- 3015937050
Source Documents#
Other 510(k) Records For Product Code MDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | 2009-01-26 |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | 2006-04-14 |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | 2005-10-17 |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | 2004-08-12 |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | 2003-06-18 |
| K024160 | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | 2003-03-17 |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | 2002-10-16 |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. | Medtrade Products , Ltd. | 2002-02-14 |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | 2001-05-30 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | 2001-03-19 |
Legacy Summary#
summary
FDA Review#
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