The following data is part of a premarket notification filed by Ethicon Endo-sugery, Llc with the FDA for Ligamax 5.
Device ID | K110699 |
510k Number | K110699 |
Device Name: | LIGAMAX 5 |
Classification | Clip, Implantable |
Applicant | ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
Contact | Emily Kruetzkamp |
Correspondent | Emily Kruetzkamp ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-14 |
Decision Date | 2011-03-25 |
Summary: | summary |