The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Disposable Multiple Ligating Clip.
Device ID | K820837 |
510k Number | K820837 |
Device Name: | DISPOSABLE MULTIPLE LIGATING CLIP |
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 | 1982-03-26 |
Decision Date | 1982-05-28 |