510(k) K834515
K834515 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "FIXATION STAPLE KIT - DLIDE HAMMER". The FDA issued a decision of Substantially Equivalent on April 23, 1984. The device falls under product code HXJ (Staple Driver), 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
- April 23, 1984
- Date Received
- December 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple Driver
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type