The following data is part of a premarket notification filed by Medtrade Products Ltd. with the FDA for Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2nd Skin Silicone Scar Therapy Gel, Model 09916030..
| Device ID | K014036 |
| 510k Number | K014036 |
| Device Name: | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire Cw1 6gl, GB Cw1 6gl |
| Contact | Jonathan D Ranfield |
| Correspondent | Jonathan D Ranfield MEDTRADE PRODUCTS LTD. ELECTRA HOUSE CREWE BUSINESS PARK Crewe, Cheshire Cw1 6gl, GB Cw1 6gl |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-02-14 |
| Summary: | summary |