The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ligaclip Multiple Clip Applier.
Device ID | K771412 |
510k Number | K771412 |
Device Name: | LIGACLIP MULTIPLE CLIP APPLIER |
Classification | Applier, Surgical, Clip |
Applicant | ETHICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDO |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-08-01 |
Decision Date | 1977-11-28 |