510(k) K941605
K941605 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1994
- Date Received
- April 1, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Manual Surgical Instrument
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type