The following data is part of a premarket notification filed by Crystal Medical Products, Inc. with the FDA for Axicare Cm-14 Automatic Breast Pump.
| Device ID | K853107 |
| 510k Number | K853107 |
| Device Name: | AXICARE CM-14 AUTOMATIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | CRYSTAL MEDICAL PRODUCTS, INC. 118 BARRINGTON COMMONS PLAZA SUITE 240 Barrington, IL 60010 |
| Contact | William J Frait |
| Correspondent | William J Frait CRYSTAL MEDICAL PRODUCTS, INC. 118 BARRINGTON COMMONS PLAZA SUITE 240 Barrington, IL 60010 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-11-19 |