510(k) K942695
- Device
- Tri Block Polumer Gel Sheeting
- Applicant
- SILIPOS, INC.
- 510(k) number
- K942695
- Product code
- MDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-11-10
- Date received
- 1994-06-07
- 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
- ROBERT L GOULD
- Address
- 366 Madison Ave. Suite 1616 New York NY US 10017 10017
FDA Registration Numbers#
- 9681544
- 3025430795
- 3008951066
- 3019867040
- 3021630959
- 3027517726
- 3032812695
- 1038758
- 3005855077
- 1000641183
- 3036893546
- 3016450032
- 3009655869
- 1000119796
- 8022978
- 3012314549
- 3012187635
- 3008693666
- 3018101380
- 3014312726
- 8023033
- 3015277818
- 3035786168
- 2529394
- 3007607706
- 3010198795
- 3010256218
- 3016758972
- 3005630901
- 3008242042
- 3044026004
- 3010034367
- 3030067857
- 3011210302
- 3015414875
- 1000115322
- 3045058049
- 3015745029
- 1000524645
- 3042261316
- 3009548473
- 3007841320
- 3031481777
- 3013037032
- 3007648359
- 3036497112
- 3008132398
- 2028924
- 3015172365
- 3003348807
- 3023662442
- 3030229896
- 3031841907
- 3034669683
- 3010160370
- 3012430748
- 2022548
- 3031184338
- 3009317711
- 3005951403
- 1219795
- 3003897287
- 3033536319
- 3044447218
- 3009562494
- 3010401517
- 3003799320
- 3005369309
- 9616572
- 3023855650
- 3014795329
- 3040389256
- 3005083505
- 3015821396
- 3042276434
- 3021013122
- 3031582434
- 3013530949
- 3030726486
- 3001744192
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 |