The following data is part of a premarket notification filed by Monterey Laboratories, Inc. with the FDA for Infa Complete Breast Pump & Milk Storag.
| Device ID | K840325 |
| 510k Number | K840325 |
| Device Name: | INFA COMPLETE BREAST PUMP & MILK STORAG |
| Classification | Pump, Breast, Non-powered |
| Applicant | MONTEREY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-25 |
| Decision Date | 1984-03-05 |