510(k) K840735
K840735 is an FDA 510(k) premarket notification submitted by Amtech Scientific, Inc. for the device "FEMORAL CEMENT REMOVAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 14, 1984. The device falls under product code HWX (Tap, Bone), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1984
- Date Received
- February 21, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tap, Bone
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type