The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Pancreatic Drainage Tube.
Device ID | K021672 |
510k Number | K021672 |
Device Name: | PANCREATIC DRAINAGE TUBE |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Laura Storms-tyler |
Correspondent | Laura Storms-tyler AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-21 |
Decision Date | 2003-04-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170152303 | K021672 | 000 |
14953170152020 | K021672 | 000 |
14953170152006 | K021672 | 000 |
14953170461214 | K021672 | 000 |
14953170461191 | K021672 | 000 |
14953170461092 | K021672 | 000 |
14953170461078 | K021672 | 000 |
14953170461054 | K021672 | 000 |
14953170461030 | K021672 | 000 |
14953170461016 | K021672 | 000 |
14953170460996 | K021672 | 000 |
14953170460972 | K021672 | 000 |
14953170152044 | K021672 | 000 |
14953170152068 | K021672 | 000 |
14953170152280 | K021672 | 000 |
14953170152266 | K021672 | 000 |
14953170152242 | K021672 | 000 |
14953170152228 | K021672 | 000 |
14953170152204 | K021672 | 000 |
14953170152181 | K021672 | 000 |
14953170152167 | K021672 | 000 |
14953170152143 | K021672 | 000 |
14953170152129 | K021672 | 000 |
14953170152105 | K021672 | 000 |
14953170152082 | K021672 | 000 |
14953170460958 | K021672 | 000 |