The following data is part of a premarket notification filed by Crystal Medical Products, Inc. with the FDA for Crystal Manual Breast Pump.
| Device ID | K850242 |
| 510k Number | K850242 |
| Device Name: | CRYSTAL MANUAL BREAST PUMP |
| Classification | Pump, Breast, Non-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 | HGY |
| CFR Regulation Number | 884.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-02-25 |