510(k) K873066
K873066 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "ACROMED SCREW DRIVER". The FDA issued a decision of Substantially Equivalent on September 2, 1987. The device falls under product code HXX (Screwdriver), 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
- September 2, 1987
- Date Received
- August 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screwdriver
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type