The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dex-cell Hysteroscopy Fluid Delivery Device.
| Device ID | K892001 |
| 510k Number | K892001 |
| Device Name: | DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE |
| Classification | Insufflator, Hysteroscopic |
| Applicant | DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Contact | Mary K Bruch |
| Correspondent | Mary K Bruch DEXIDE, INC. P.O. BOX 185789 Ft. Worth, TX 76181 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-06-16 |