The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan Heifetz Aneurysm Elgiloy Clip System.
| Device ID | K960372 |
| 510k Number | K960372 |
| Device Name: | SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM |
| Classification | Clip, Aneurysm |
| Applicant | SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Contact | Ken Blake |
| Correspondent | Ken Blake SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-26 |
| Decision Date | 1996-04-26 |
| Summary: | summary |