510(k) K933570
K933570 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "RESOLUTION(TM) HIP STEM". The FDA issued a decision of SN on March 7, 1994. The device falls under product code LJW (Tracheotome), a Class I device regulated under 21 CFR 874.4420. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 7, 1994
- Date Received
- July 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tracheotome
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type