510(k) K850288
K850288 is an FDA 510(k) premarket notification submitted by Beecher Medical Diagnostic Instrumentation for the device "HEPATIC PARENCHYMAL SUCTION DISSECTOR". The FDA issued a decision of Substantially Equivalent on March 18, 1985. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Beecher Medical Diagnostic Instrumentation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1985
- Date Received
- January 24, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dissector, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type