510(k) K862474
K862474 is an FDA 510(k) premarket notification submitted by Hall Surgical, Division of Zimmer, Inc. for the device "HALL STERNUM SAW". The FDA issued a decision of Substantially Equivalent on July 17, 1986. The device falls under product code DWH (Blade, Saw, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 878.4820. 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 17, 1986
- Date Received
- June 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blade, Saw, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type