The following data is part of a premarket notification filed by Medical Packaging Corp. with the FDA for Cytology Brushes.
| Device ID | K864323 |
| 510k Number | K864323 |
| Device Name: | CYTOLOGY BRUSHES |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MEDICAL PACKAGING CORP. 7252 GREENTREE RD. Bethesda, MD 20817 |
| Contact | Joyce T Davis |
| Correspondent | Joyce T Davis MEDICAL PACKAGING CORP. 7252 GREENTREE RD. Bethesda, MD 20817 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-03 |
| Decision Date | 1987-01-09 |