The following data is part of a premarket notification filed by Crystal Medical Products, Inc. with the FDA for Crystal Medical Milk Collection Kit.
Device ID | K842766 |
510k Number | K842766 |
Device Name: | CRYSTAL MEDICAL MILK COLLECTION KIT |
Classification | Pump, Breast, Powered |
Applicant | CRYSTAL MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-16 |
Decision Date | 1984-09-25 |