The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Heifetz Aneurysm Clip, Lmm Blade.
Device ID | K790413 |
510k Number | K790413 |
Device Name: | HEIFETZ ANEURYSM CLIP, LMM BLADE |
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 | 1979-02-26 |
Decision Date | 1979-03-16 |