510(k) K961101
K961101 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER CEMENT REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1996. The device falls under product code LZV (System, Cement Removal Extraction), a Class II device regulated under 21 CFR 888.4580. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1996
- Date Received
- March 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cement Removal Extraction
- Device Class
- Class II
- Regulation Number
- 888.4580
- Review Panel
- OR
- Submission Type