510(k) K873688
K873688 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL". The FDA issued a decision of Substantially Equivalent on October 26, 1987. The device falls under product code JXH (Methyl Methacrylate For Aneurysmorrhaphy), a Class II device regulated under 21 CFR 882.5030. Dentsply Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1987
- Date Received
- September 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methyl Methacrylate For Aneurysmorrhaphy
- Device Class
- Class II
- Regulation Number
- 882.5030
- Review Panel
- NE
- Submission Type