The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Pre-filled Syringe For Koala Iup.
| Device ID | K973746 |
| 510k Number | K973746 |
| Device Name: | PRE-FILLED SYRINGE FOR KOALA IUP |
| Classification | Transducer, Pressure, Intrauterine |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | Dean Wallace |
| Correspondent | Dean Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | HFN |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1997-11-24 |
| Summary: | summary |