The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Bc Brushes.
Device ID | K902737 |
510k Number | K902737 |
Device Name: | BC BRUSHES |
Classification | Endoscopic Cytology Brush |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Daniel J Dillon |
Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | FDX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-21 |
Decision Date | 1990-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170285650 | K902737 | 000 |
14953170042833 | K902737 | 000 |
14953170042819 | K902737 | 000 |
00821925001442 | K902737 | 000 |
00821925001435 | K902737 | 000 |