The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Ameda Hygienikit.
| Device ID | K011519 |
| 510k Number | K011519 |
| Device Name: | AMEDA HYGIENIKIT |
| Classification | Pump, Breast, Non-powered |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810725023171 | K011519 | 000 |
| 10810725020699 | K011519 | 000 |
| 10810725020682 | K011519 | 000 |
| 10810725020613 | K011519 | 000 |
| 10810725020606 | K011519 | 000 |
| 10810725020590 | K011519 | 000 |
| 10810725020583 | K011519 | 000 |
| 10810725020576 | K011519 | 000 |
| 10810725020521 | K011519 | 000 |
| 00810725020128 | K011519 | 000 |
| 20810725020115 | K011519 | 000 |
| 10810725020101 | K011519 | 000 |
| 00810725020029 | K011519 | 000 |
| 10810725020019 | K011519 | 000 |
| 00810725022702 | K011519 | 000 |
| 10810725020705 | K011519 | 000 |
| 10810725020729 | K011519 | 000 |
| 10810725021627 | K011519 | 000 |
| 10810725023164 | K011519 | 000 |
| 10810725023157 | K011519 | 000 |
| 10810725023140 | K011519 | 000 |
| 10810725023126 | K011519 | 000 |
| 10810725023119 | K011519 | 000 |
| 10810725023096 | K011519 | 000 |
| 10810725023089 | K011519 | 000 |
| 10810725023041 | K011519 | 000 |
| 10810725023034 | K011519 | 000 |
| 10810725023027 | K011519 | 000 |
| 10810725023010 | K011519 | 000 |
| 10810725022853 | K011519 | 000 |
| 10810725022464 | K011519 | 000 |
| 10810725022396 | K011519 | 000 |
| 00810725025437 | K011519 | 000 |