510(k) K854254
K854254 is an FDA 510(k) premarket notification submitted by Medmetric Corp. for the device "TENSION-ISOMETER". The FDA issued a decision of Substantially Equivalent on November 15, 1985. The device falls under product code LXI (Guide, Drill, Ligament), a Class I device regulated under 21 CFR 878.4820. Medmetric Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1985
- Date Received
- October 22, 1985
- 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