The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Sonosurg Trocar.
Device ID | K042160 |
510k Number | K042160 |
Device Name: | SONOSURG TROCAR |
Classification | Instrument, Ultrasonic Surgical |
Applicant | AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Tina Steffanie-oak |
Correspondent | Tina Steffanie-oak AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
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 | 2004-08-10 |
Decision Date | 2005-01-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170208482 | K042160 | 000 |
14953170170499 | K042160 | 000 |
14953170061674 | K042160 | 000 |
14953170445818 | K042160 | 000 |