The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ligaclip 20/20* Multiple Clip Applier.
Device ID | K864102 |
510k Number | K864102 |
Device Name: | LIGACLIP 20/20* MULTIPLE CLIP APPLIER |
Classification | Clip, Implantable |
Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
Contact | Robert H O'holla |
Correspondent | Robert H O'holla ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-21 |
Decision Date | 1986-11-05 |