The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Dymax Endovaginal Biopsy Guide.
| Device ID | K894415 |
| 510k Number | K894415 |
| Device Name: | DYMAX ENDOVAGINAL BIOPSY GUIDE |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Contact | Irene R Skolnick |
| Correspondent | Irene R Skolnick DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-10-25 |