510(k) K854844
K854844 is an FDA 510(k) premarket notification submitted by Engineering, Inc. for the device "LS1000 SURGICAL ASPIRATOR II". The FDA issued a decision of SN on February 12, 1986. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Engineering, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 12, 1986
- Date Received
- December 4, 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