510(k) K863293
K863293 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "DISPOSABLE SUCTION CANNULA NO. 902008-000". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1986
- Date Received
- August 25, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type