The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Pap-pak Cytobrush Kit.
| Device ID | K870398 |
| 510k Number | K870398 |
| Device Name: | PAP-PAK CYTOBRUSH KIT |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MEDICAL PACKAGING CORP. 14610 LANARK ST. Panorama City, CA 91402 |
| Contact | Frederic L Nason |
| Correspondent | Frederic L Nason MEDICAL PACKAGING CORP. 14610 LANARK ST. Panorama City, CA 91402 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-02 |
| Decision Date | 1987-02-25 |