The following data is part of a premarket notification filed by Intl. Cytobrush, Inc. with the FDA for Endobrush(tm) Device; Omnibrush.
| Device ID | K897070 |
| 510k Number | K897070 |
| Device Name: | ENDOBRUSH(TM) DEVICE; OMNIBRUSH |
| Classification | Brush, Endometrial |
| Applicant | INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Contact | Tse, Ph.d. |
| Correspondent | Tse, Ph.d. INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-22 |
| Decision Date | 1990-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003295 | K897070 | 000 |