510(k) K850946
K850946 is an FDA 510(k) premarket notification submitted by Medicalex for the device "SURGICAL ASPIRATOR". The FDA issued a decision of SN on September 16, 1985. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Medicalex has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 16, 1985
- Date Received
- March 7, 1985
- 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