EXSUDEX WOUND DRAINAGE PUMP
FDA 510(k) clearance K082311 · decided 2008-10-08
Clearance details
- K-number
- K082311
- Device name
- EXSUDEX WOUND DRAINAGE PUMP
- Applicant
- The Medical Company
- Decision
- Substantially Equivalent
- Date received
- 2008-08-13
- Decision date
- 2008-10-08
- Days to decision
- 56 days
- Clearance type
- Abbreviated
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Amersfoort, NL
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch The Medical Company
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.