NEODYNE DRESSING
FDA 510(k) clearance K112131 · decided 2011-09-29
Clearance details
- K-number
- K112131
- Device name
- NEODYNE DRESSING
- Applicant
- Neodyne Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-26
- Decision date
- 2011-09-29
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- MDA
- Device class
- 1
- Regulation number
- 878.4025
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| CORELEADER SCAR-DIMMER (K111733) | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| BEAU RX SCAR CARE GEL (K083718) | Beau RX Solutions, LLC | 2009-01-26 |
| KELO-COTE SPRAY (K053481) | Advanced Bio-Technologies, Inc. | 2006-04-14 |
| NEWGEL AND NEWGEL PLUS E (K041704) | Newmedical Technology, Inc. | 2005-10-17 |
| HANSON SCAR ADE (K040307) | Hanson Medical, Inc. | 2004-08-12 |
| CURAD SCAR THERAPY (K024057) | Beiersdorf, Inc. | 2003-06-18 |
| NEOSPORIN SCAR SOLUTION (K024160) | Warner-Lambert Co. | 2003-03-17 |
| DIMISIL SCAR GEL (K023678) | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 |
| OLEEVA FABRIC (K023136) | Bio Med Sciences, Inc. | 2002-10-16 |
| MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. (K014036) | Medtrade Products , Ltd. | 2002-02-14 |
| GELZONE (K013732) | Implantech Associates, Inc. | 2002-02-07 |
| CONFORM SHEETING, MODEL IGEL (K012419) | Implantech Associates, Inc. | 2001-10-24 |
Recalls involving this device
No recalls on record reference this clearance.