510(k) K173389
K173389 is an FDA 510(k) premarket notification submitted by Rex Medical, L.P. for the device "Rex Medical Aspiration Pump". The FDA issued a decision of Substantially Equivalent on January 30, 2018. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Rex Medical, L.P. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2018
- Date Received
- October 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type