The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Mothers Touch One Hand Breast Pump.
| Device ID | K912355 |
| 510k Number | K912355 |
| Device Name: | MOTHERS TOUCH ONE HAND BREAST PUMP |
| Classification | Pump, Breast, Non-powered |
| Applicant | HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Contact | Johm F.lemker |
| Correspondent | Johm F.lemker HOLLISTER, INC. C/O BURDIT,RADZIUS,CHARTERED 333 W.WACKER DR. Chicago, IL 60606 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-28 |
| Decision Date | 1993-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810725022723 | K912355 | 000 |
| 10810725020545 | K912355 | 000 |
| 10810725020552 | K912355 | 000 |
| 10810725020644 | K912355 | 000 |
| 10810725020651 | K912355 | 000 |
| 10810725020675 | K912355 | 000 |
| 00810725020739 | K912355 | 000 |
| 10810725020743 | K912355 | 000 |
| 10810725022358 | K912355 | 000 |
| 10810725022488 | K912355 | 000 |
| 10810725020378 | K912355 | 000 |