The following data is part of a premarket notification filed by The Medical Company with the FDA for Exsudex Wound Drainage Pump.
| Device ID | K082311 |
| 510k Number | K082311 |
| Device Name: | EXSUDEX WOUND DRAINAGE PUMP |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | THE MEDICAL COMPANY P.O. BOX 2116 Amersfoort, NL 3800 Cc |
| Contact | Harm Jaap Smit |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 87181048900770 | K082311 | 000 |
| 87181048900602 | K082311 | 000 |
| 87181048900534 | K082311 | 000 |
| 87181048900466 | K082311 | 000 |
| 87181048900398 | K082311 | 000 |
| 87181048900220 | K082311 | 000 |
| 87181048900152 | K082311 | 000 |
| 08718104890466 | K082311 | 000 |
| 08718104890459 | K082311 | 000 |