The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ultracision Laparosonic Coagulating Shears (lcs-5(lcsk5 And Lcsb5)).
Device ID | K980099 |
510k Number | K980099 |
Device Name: | ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) |
Classification | Instrument, Ultrasonic Surgical |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Larry Carrier |
Correspondent | Larry Carrier ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-12 |
Decision Date | 1998-04-09 |
Summary: | summary |