The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Ameda Disposable Vacuum Assist Cup With Fluid Retention Trap.
| Device ID | K980976 |
| 510k Number | K980976 |
| Device Name: | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joeseph S Tokarz |
| Correspondent | Joeseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-08-21 |
| Summary: | summary |