The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Intrauterine Catheter Tip.
| Device ID | K790678 | 
| 510k Number | K790678 | 
| Device Name: | INTRAUTERINE CATHETER TIP | 
| Classification | Monitor, Pressure, Intrauterine | 
| Applicant | SONICAID, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | KXO | 
| CFR Regulation Number | 884.2700 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1979-04-09 | 
| Decision Date | 1979-05-11 |