The following data is part of a premarket notification filed by Gerber Products Co. with the FDA for Gerber Precious Care Electric Breast Pump.
Device ID | K902552 |
510k Number | K902552 |
Device Name: | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP |
Classification | Pump, Breast, Non-powered |
Applicant | GERBER PRODUCTS CO. 445 STATE ST. Fremont, MI 49413 |
Contact | John J James |
Correspondent | John J James GERBER PRODUCTS CO. 445 STATE ST. Fremont, MI 49413 |
Product Code | HGY |
CFR Regulation Number | 884.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-08 |
Decision Date | 1990-09-26 |