The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic 10cm Combination Hook Blade.
Device ID | K072203 |
510k Number | K072203 |
Device Name: | HARMONIC 10CM COMBINATION HOOK BLADE |
Classification | Instrument, Ultrasonic Surgical |
Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
Contact | Elizabeth Miller |
Correspondent | Elizabeth Miller ETHICON ENDO-SURGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
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 | 2007-08-08 |
Decision Date | 2007-09-25 |
Summary: | summary |