510(k) K983009
K983009 is an FDA 510(k) premarket notification submitted by Etex Corp. for the device "BSM- BONE SUBSTITUTE MATERIAL". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Etex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1998
- Date Received
- August 28, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methyl Methacrylate For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5300
- Review Panel
- NE
- Submission Type