The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Heifetz Intracranial Aneurysm Clips.
| Device ID | K832795 |
| 510k Number | K832795 |
| Device Name: | HEIFETZ INTRACRANIAL ANEURYSM CLIPS |
| Classification | Clip, Aneurysm |
| Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HCH |
| CFR Regulation Number | 882.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-11-25 |