510(k) K915692
K915692 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "CANNULATED DRILL BIT". The FDA issued a decision of Substantially Equivalent on January 16, 1992. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1992
- Date Received
- December 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bit, Drill
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type