510(k) K931540
K931540 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "UNIVERSAL BONE CEMENT KIT". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1994
- Date Received
- March 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement Obturator
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type