510(k) K875054
K875054 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED ADS BONE NAIL DRIVER". The FDA issued a decision of Substantially Equivalent on January 28, 1988. The device falls under product code HWR (Driver, Prosthesis), a Class I device regulated under 21 CFR 888.4540. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1988
- Date Received
- December 9, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Prosthesis
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type