510(k) K772376
K772376 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "NEIVERT OSTEOTOME". The FDA issued a decision of Substantially Equivalent on March 9, 1978. The device falls under product code KDG (Chisel (Osteotome)), a Class I device regulated under 21 CFR 878.4820. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chisel (Osteotome)
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type