The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Sonosurg Ultrasonic Surgical System.
Device ID | K041566 |
510k Number | K041566 |
Device Name: | SONOSURG ULTRASONIC SURGICAL SYSTEM |
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 | 2004-06-10 |
Decision Date | 2004-09-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170027123 | K041566 | 000 |
04953170183171 | K041566 | 000 |
14953170183123 | K041566 | 000 |
14953170182959 | K041566 | 000 |
14953170183215 | K041566 | 000 |
04953170183072 | K041566 | 000 |
04953170183058 | K041566 | 000 |
04953170183034 | K041566 | 000 |
04953170028533 | K041566 | 000 |