510(k) K891887
K891887 is an FDA 510(k) premarket notification submitted by Zinnanti Surgical Instruments, Inc. for the device "OSTEOTOMES, VARIOUS TYPES". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code GFI (Osteotome, Manual), a Class I device regulated under 21 CFR 878.4800. Zinnanti Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1989
- Date Received
- March 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osteotome, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type