510(k) K943583
K943583 is an FDA 510(k) premarket notification submitted by Enterprise Medical Corp. for the device "KERRISON RONGEURS". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Enterprise Medical Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1995
- Date Received
- July 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type