The following data is part of a premarket notification filed by Clinical Innovations, Inc. with the FDA for Kiwi Soft Cup With Palm Pump Model Number Vfe-6000s, Kiwi Mushroom Cup With Palm Pump Model Vfe-6000m.
| Device ID | K981260 |
| 510k Number | K981260 |
| Device Name: | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Contact | Wm D Wallace |
| Correspondent | Wm D Wallace CLINICAL INNOVATIONS, INC. 6477 SOUTH COTTONWOOD ST. Murray, UT 84107 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814247020660 | K981260 | 000 |
| 20814247020653 | K981260 | 000 |
| 20814247020646 | K981260 | 000 |
| 20814247020639 | K981260 | 000 |
| 20814247020622 | K981260 | 000 |
| 20814247020004 | K981260 | 000 |