510(k) K770205
K770205 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "CEMENT CHISELS". The FDA issued a decision of Substantially Equivalent on February 8, 1977. The device falls under product code HWA (Impactor), a Class I device regulated under 21 CFR 888.4540. Depuy, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1977
- Date Received
- January 31, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Impactor
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type