510(k) K842823
K842823 is an FDA 510(k) premarket notification submitted by Cher Mel Corp. for the device "CHERMEL OSTEOTOMES". The FDA issued a decision of Substantially Equivalent on August 2, 1984. The device falls under product code GFI (Osteotome, Manual), a Class I device regulated under 21 CFR 878.4800. Cher Mel Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1984
- Date Received
- July 19, 1984
- 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