The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Sonohysterography Biopsy Device.
| Device ID | K060908 |
| 510k Number | K060908 |
| Device Name: | SONOHYSTEROGRAPHY BIOPSY DEVICE |
| Classification | Cannula, Injector, Uterine, Endometrial Biopsy |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Cindy Rumple |
| Correspondent | Cindy Rumple COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | PGK |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-06-29 |
| Summary: | summary |