The following data is part of a premarket notification filed by Simex Medizintechnik Gmbh with the FDA for Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-ex200 And Sim-ex300.
| Device ID | K113291 |
| 510k Number | K113291 |
| Device Name: | SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | SIMEX MEDIZINTECHNIK GMBH P.O. BOX 1207 Deisslingen, DE D-78649 |
| Contact | Hamid Khosrowshahi |
| Correspondent | Hamid Khosrowshahi SIMEX MEDIZINTECHNIK GMBH P.O. BOX 1207 Deisslingen, DE D-78649 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-08 |
| Decision Date | 2012-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052262385568 | K113291 | 000 |
| 04052262385551 | K113291 | 000 |