510(k) K862529
K862529 is an FDA 510(k) premarket notification submitted by Hall Surgical, Division of Zimmer, Inc. for the device "HALL STERILE BUR". The FDA issued a decision of Substantially Equivalent on July 15, 1986. The device falls under product code HTT (Burr, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Hall Surgical, Division of Zimmer, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1986
- Date Received
- July 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burr, Orthopedic
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type