The following data is part of a premarket notification filed by Intl. Cytobrush, Inc. with the FDA for Pap Smear Kit.
| Device ID | K861389 |
| 510k Number | K861389 |
| Device Name: | PAP SMEAR KIT |
| Classification | Spatula, Cervical, Cytological |
| Applicant | INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Contact | Tenny P Tse |
| Correspondent | Tenny P Tse INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-14 |
| Decision Date | 1986-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937010958 | K861389 | 000 |
| 20888937009945 | K861389 | 000 |
| 60888937021402 | K861389 | 000 |
| 20888937003165 | K861389 | 000 |
| 20888937022388 | K861389 | 000 |