The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Ameda/egnell Dolphin Dispo-soft Vacuum Extractor.
| Device ID | K895700 |
| 510k Number | K895700 |
| Device Name: | AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Contact | John F Lemker |
| Correspondent | John F Lemker HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-22 |
| Decision Date | 1990-04-02 |