The following data is part of a premarket notification filed by Innovative Therapies, Inc. with the FDA for Sved Wound Treatment System.
| Device ID | K093564 |
| 510k Number | K093564 |
| Device Name: | SVED WOUND TREATMENT SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | INNOVATIVE THERAPIES, INC. 12 MEEM AVE, SUITE C Gaithersburg, MD 20877 |
| Contact | Judith Harbour |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2009-11-25 |
| Summary: | summary |