510(k) K910712
K910712 is an FDA 510(k) premarket notification submitted by Physio Systems, Inc. for the device "VILLAN (VIDEO LIFT LINK ANALYSIS)". The FDA issued a decision of Substantially Equivalent on May 21, 1991. The device falls under product code LXI (Guide, Drill, Ligament), a Class I device regulated under 21 CFR 878.4820. Physio Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1991
- Date Received
- February 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guide, Drill, Ligament
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- OR
- Submission Type