The following data is part of a premarket notification filed by Digene Corp. with the FDA for Digene Cervical Brush.
| Device ID | K971586 |
| 510k Number | K971586 |
| Device Name: | DIGENE CERVICAL BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Contact | Constance A Finch |
| Correspondent | Constance A Finch DIGENE CORP. 9000 VIRGINIA MANOR RD., Beltsville, MD 20705 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14053228010354 | K971586 | 000 |