The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device Cc-220dr.
Device ID | K192164 |
510k Number | K192164 |
Device Name: | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi, JP 192-8507 |
Contact | Toshiyuki Nakajima |
Correspondent | Jonathan Gilbert Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-09 |
Decision Date | 2020-03-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170406178 | K192164 | 000 |