510(k) K981387
- Device
- EVANESCE SCAR MANAGEMENT SYSTEM
- Applicant
- MEDICAL SCIENTIFIC, INC.
- 510(k) number
- K981387
- Product code
- MDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-10
- Date received
- 1998-04-16
- 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
- PAUL NARDELLA
- Address
- 125 John Hancock Rd. Taunton MA US 02780 02780
FDA Registration Numbers#
- 3005083505
- 3009843176
- 3012314549
- 3025430795
- 3013298431
- 3018101380
- 3008951066
- 3005855077
- 3004537835
- 3007125336
- 1000119796
- 3009317711
- 3041329419
- 3037918935
- 3019769561
- 3014982332
- 8043484
- 3012034017
- 3011210302
- 3025413691
- 3004713654
- 3010256218
- 3016170587
- 2022548
- 3007048057
- 3036893546
- 3035786168
- 3010043561
- 3010957766
- 8023033
- 3012818008
- 3021013122
- 3005951403
- 1058063
- 3043226252
- 1000524645
- 8030107
- 3042276434
- 2939821
- 3031841907
- 3015821396
- 3021821373
- 3033891906
- 3007966889
- 3005621376
- 3010700223
- 3016245348
- 3014146451
- 3007257878
- 3023855650
- 3004967086
- 2031444
- 3005488444
- 3016450032
- 3013496867
- 3012852163
- 3042285110
- 3016585381
- 3031218457
- 3032812695
- 3023662442
- 3049809155
- 3006227741
- 3013530949
- 3008242042
- 1062964
- 3010822231
- 3010380285
- 3013057573
- 3044150131
- 3030746897
- 3003897287
- 3031184338
- 3044026004
- 3021090069
- 3025430561
- 3015781779
- 3012706495
- 3009192857
Source Documents#
Other 510(k) Records For Product Code MDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | 2011-09-29 |
| 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 |
Legacy Summary#
summary
FDA Review#
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