The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Egnell Elite.
| Device ID | K950531 |
| 510k Number | K950531 |
| Device Name: | EGNELL ELITE |
| Classification | Pump, Breast, Powered |
| Applicant | HOLLISTER, INC. 755 INDUSTRIAL DR. Cary, IL 60013 -1993 |
| Contact | Roland Muller |
| Correspondent | Roland Muller HOLLISTER, INC. 755 INDUSTRIAL DR. Cary, IL 60013 -1993 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-07 |
| Decision Date | 1995-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810725022894 | K950531 | 000 |
| 00810725021569 | K950531 | 000 |
| 00810725021545 | K950531 | 000 |
| 00810725021552 | K950531 | 000 |