The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Hemoclip Ligating Clips M/large.
Device ID | K841548 |
510k Number | K841548 |
Device Name: | HEMOCLIP LIGATING CLIPS M/LARGE |
Classification | Clip, Implantable |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-16 |
Decision Date | 1984-08-14 |