510(k) K960372
K960372 is an FDA 510(k) premarket notification submitted by Scanlan Intl., Inc. for the device "SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1996. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Scanlan Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1996
- Date Received
- January 26, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Aneurysm
- Device Class
- Class II
- Regulation Number
- 882.5200
- Review Panel
- NE
- Submission Type